81 Regulatory Affairs Specialist jobs in South Africa
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.
This role is part of Alcon's Quality & Regulatory Affairs function, a team that ensures our products are in compliance with global, local, and internal regulations and meet the strictest standards of quality as we help people see brilliantly. The Regulatory Affairs Specialist is primarily responsible for ensuring product compliance with regulations, and maintaining product registrations. You will build effective relationships with internal collaborators and regulatory authorities to support strategic decisions and compliance for the Africa Region while you are based in Midrand. Your daily responsibilities will include:
- Perform specialized tasks and conduct independent research within the Regulatory Affairs Strategy team to optimize outcomes and contribute to project goals
- Coordinate product submissions, renewals, and updates by liaising with plants, agents, and authorities to ensure timely submissions and approvals
- Oversee promotional material approval for Alcon portfolio, ensuring ethical conduct and compliance with laws, codes, and regulations
- Develop regulatory strategies for new product introductions and product changes, maintaining regulatory compliance to drive competitive advantage
- Support products in the medical device and/or pharmaceutical family, ensuring adherence to relevant regulations
- Adhere to Good Practice (GxP) regulations by following Standard Operating Procedures (SOPs), maintaining accurate documentation, ensuring quality control, and completing required training
- Meet individual job requirements and contribute to the organization's overall compliance and continuous improvement in operations
WE ARE SEEKING:
- Bachelor's degree in health sciences
- Minimum 3-5 years of experience in a international Pharma/Medical device company
- Fluent English. Written and spoken.
- Demonstrated ability to lead and work effectively with multiple stakeholders – internal and external and excellent communication Adherence to timelines for key regulatory submissions.
- Ability to support the business by communicating effectively, managing issues proactively, resolving conflicts and mitigating risks
- Strong writing and detail-oriented skills in the form of high-quality regulatory submission documents
- Nice to have experience in Veeva, SAHPHRA submission platforms
- Nice to have experience in Regulatory submissions in export markets
HOW YOU CAN THRIVE AT ALCON:
- Comprehensive benefits package
- Training and continuous development; Be part of a high performing ophthalmology company with a lot of opportunities to further develop your professional career.
- International exposure
- Open, friendly and collaborative culture; Work in a challenging environment with an outstanding team that will supportto achieve goals and performance.
Alcon Careers
See your impact at
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.
Find Jobs for Employees
Find Jobs for Contingent Worker
Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
Product Compliance Specialist
Location:
Remote (South Africa)
Salary:
R30,000 - R40,000 per month
Our client, a leader in e-commerce consulting, is seeking a Product Compliance Specialist to join their compliance team.
You will ensure products meet regulatory standards across the UK and EU, providing expert advice on labelling, testing, ingredients, and manufacturing compliance for a diverse range of consumer products.
Key Responsibilities
- Manage and deliver compliance-based client services to ensure regulatory compliance
- Provide expert knowledge on products, ingredients, manufacturing standards, testing, and regulations.
- Liaise effectively with Trading Standards and European member states regarding consumer products manufactured and sold inside and outside the EU.
- Advise clients on labelling compliance and requirements across multiple product categories.
- Use EU and UK regulations to create detailed, professional compliance reports for clients.
- Keep up to date with regulatory changes and guidance from relevant agencies such as FSA, MHRA, and ESFA.
- Provide excellent customer service, ensuring responses and deliverables meet agreed SLAs.
- Support clients with technical documentation and complete product registrations for UK and EU markets, including cosmetics and medical devices.
- Conduct research on complex product categories, identifying trends and providing analysis.
Essential Qualifications & Skills
- A scientific degree in Environmental Science, Food Science, Cosmetics, Pharmaceuticals, Chemistry, or a related field
(Essential) - Proficiency with Microsoft 365.
- Strong attention to detail and organizational skills.
- Excellent communication and analytical abilities.
Preferred Skills
- Multilingual or bilingual proficiency in
French, German, Spanish, or English
.
If you want to develop in an industry-leading international environment, this role is for you
Senior Regulatory Affairs Specialist
Posted today
Job Viewed
Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeYou are an administratively proficient person, who despite routine also likes to interact across the globe to complete work, being able to be part of a team that delivers on time sensitive projects. Your laptop is your companion and gateway to work.
The purpose of the job is to ensure regulatory compliance for the region of responsibility, managing projects and assignments to ensure that Medtronic therapies are approved, and compliance is maintained across all facets of premarket and post market surveillance and vigilance. The position is a hybrid (office and home) position based in Midrand, Gauteng and while travel is minimal, it cannot be discounted.
Responsibilities may include the following and other duties may be assigned:
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections
- Leads or compiles all materials required in submissions, license renewal and annual registrations
- Monitors and improves tracking / control systems
- Keeps abreast of regulatory procedures and changes
- May direct interaction with regulatory agencies on defined matters
- Recommends strategies for earliest possible approvals of clinical trials applications
Required Knowledge and Experience:
- 5+ years of experience in Regulatory Affairs area with advanced knowledge of job area combining breadth and depth. Knowledge of project management would be advantageous
- Bachelor's Degree in a relevant field, Bachelor's Degree in Pharma is appreciated
- Ability to deal with multiple complex projects / issues simultaneously
- Strong MS office skills, with SAP experience an advantage
- Strong Integrity and ethical values
- Team player
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Implement the compliance strategy aligned to the compliance monitoring plan to assist the client business in honouring their responsibility to comply with applicable regulatory requirements through directing the compliance function through identification, assessing, managing, monitoring and report on regulatory compliance risks facing the organisation.
This position shall further provide assurance that company policies and procedures are being complied with and that the organisation meets the regulatory and company's own standards and ensure that compliance support is aligned to business strategy.
Prudential Authority Specific Responsibilities:
Ensure compliance with regulations issued by the Prudential Authority.
Stay abreast of Prudential Authority directives and guidelines relating to non-life insurers.
Monitor compliance with Prudential Authority requirements.
Prepare and submit Prudential Authority notifications, applications and reports.
Provide guidance to business and assist with implementation of compliance policies and projects.
Drafting and compiling regulatory submissions.
Qualifications:
LLB, Legal or Compliance qualification.
Successfully passed the Key Individual Regulatory Examination 1 as required by the FSCA for Licensed Compliance Officers
Phase I Approved - Category I FAIS Licensed Compliance Officer would be advantageous
Post Graduate Diploma in Compliance Management would be advantageous
Risk Qualifications will also be an advantage
Experience:
At least 5 years' Compliance experience in the financial services industry
2nd line compliance experience
In depth knowledge of legislation relating to non-life insurers, including Financial Sector Regulation Act.
On-site meetings and engagements with Regulators.
Experience that will be advantageous:
Combined assurance planning and execution
1st line compliance experience
Regulatory Complaints Handling
Job Type: Full-time
Pay: R67 000,00 - R70 000,00 per month
Application Question(s):
- Are you a registered compliance officer with the FSCA
- Have you dealt with Regulatory authorities and for how many years
- Do you have a LLB
Work Location: In person
Regulatory Compliance Specialist
Posted today
Job Viewed
Job Description
Business Unit: Discovery Bank
Function: Banking
Date: 16 Sept 2025
About Discovery
Discovery's core purpose is to make people healthier and to enhance and protect their lives. We seek out and invest in exceptional individuals who understand and support our core purpose, and whose own values align with those of Discovery. Our fast-paced and dynamic environment enables smart, self-driven people to be their best. As global thought leaders, Discovery is passionate about innovating in order to not only achieve financial success, but to ignite positive and meaningful change within our society.
About Discovery Bank
Discovery Bank is a bank like no other – a shared-value bank, designed with our clients in mind. We are all about sharing the value that clients create when they manage their money well, back with them through exceptional interest rates and rewards. Our Vitality Money programme measures how well clients manage their finances, informs them of what it means to be financially healthy, and empowers them with the knowledge to get enhanced rewards for managing their money well. If you are adaptable, a problem-solver, always questioning the way things are done, passionate about doing what is right, and obsessed with providing a quality service experience, we have a job for you where you can be your best in an environment that's safe and nurturing.
Job Purpose
The Regulatory Compliance Specialist develops, implements and oversees the regulatory compliance strategies of the bank. Assists in the establishment of an effective compliance function, framework and core processes for the bank.
Areas of responsibility may include but not limited to
- Provide Compliance advice and guidance to business and key stakeholders
- Initiates and assists in the development of key compliance policies and standard operating procedures
- Ensures that these policies and procedures are consistent with the approvals of various boards
- Identifies and assists with training and educational needs regarding compliance practices and make recommendations and develop training content
- Ensures compliance with industry regulatory standards
- Implements core Compliance principles, frameworks, processes, systems and platforms
- Implements Compliance Risk Management Framework, reviews Regulatory Universe and implementation of the Compliance Risk Management Plans and control gap analysis.
- Compiles and assists with compliance reports for Management and relevant Bank committees.
- Assists with Regulator and Audit reviews and oversee compliance actions.
- Assist with Regulatory Change and commentary processes in Discovery Bank.
- Register and maintain breaches and incidents.
Skills
Required:
- Have an understanding of and an ability to implement Compliance governance
- Have an understanding of the legislative and regulatory requirements impacting the South African Banking Sector
- Have detailed knowledge of the legislative and regulatory environment and reporting requirements imposed by South African Regulators (SARB, FSCA and NCR) specifically, but not limited to, the Banks Act, FAIS, NCA, CPA and Conduct Standards for Banks.
Preferred:
- Microsoft word, excel and power point.
Qualifications
Required:
- A Legal degree, a Bachelors degree and or a compliance qualification
- Have an understanding of the core principles of an effective Compliance function.
Work Experience
Required:
- At least 5 years Compliance experience in the financial services industry.
Preferred:
- Retail Banking experience advantageous
EMPLOYMENT EQUITY
The Company's approved Employment Equity Plan and Targets will be considered as part of the recruitment process. As an Equal Opportunities employer, we actively encourage and welcome people with various disabilities to apply.
Regulatory Compliance Administrator
Posted today
Job Viewed
Job Description
The Apex Group was established in Bermuda in 2003 and is now one of the world's largest fund administration and middle office solutions providers.
Our business is unique in its ability to reach globally, service locally and provide cross-jurisdictional services. With our clients at the heart of everything we do, our hard-working team has successfully delivered on an unprecedented growth and transformation journey, and we are now represented by over circa 13,000 employees across 112 offices worldwide.Your career with us should reflect your energy and passion.
That's why, at Apex Group, we will do more than simply 'empower' you. We will work to supercharge your unique skills and experience.
Take the lead and we'll give you the support you need to be at the top of your game. And we offer you the freedom to be a positive disrupter and turn big ideas into bold, industry-changing realities.
For our business, for clients, and for you
Description
As an Administrator within the Client Compliance Team, you are responsible for providing high quality support and assistance to the Client Compliance Officers and Senior administrators on various fund structures such as Managed Entities/Jersey Regulated Collective Investment Funds, Jersey Private Funds, non-regulated Funds and Schedule 2 entities to which Apex services are provided.
Job Specifications
- Comply with all internal policies and procedures applicable this role and the wider business
- Ensure that all prescribed training is carried out and completed in a timely manner Assist in the completion of Compliance Monitoring programme's in relation to testing and reporting.
- Assist in the completion of compliance data reconciliation and reporting
- Assist in the drafting of Client Board Compliance reports and packs
- Carry out duties in support of the Senior Members of the Apex Client Compliance Function
- Ensure Business as usual requirements and timed reporting requirements are met Undertake or assist in any planned or ad hoc project work that is identified and become involved with Apex Group initiatives in relation to regulatory, Team or Business issues, liaising with Senior Members of the team and other stakeholders as and when required.
- Assist other team members where required
- Liaise with other Apex business employees on day to day regulatory and compliance matters and assist or appropriately direct queries regarding relevant laws, orders or codes of practice
- Provide support to third party administrators in relation to administrative requests
- Assist in the maintenance and monitoring of registers
Skills Required
- Have a good working knowledge of Microsoft products, in particular Outlook, Word and Excel as well as having the capability to quickly assimilate working with Apex's key databases.
- Excellent communication skills.
- Be well organized.
- Have the flexibility and adaptability to undertake a variety of tasks at short notice if required.
- Be proactive in your approach; self-motivated, and capable of prioritising workloads as required.
- Knowledge of the Financial Services (Jersey) Law 1998, and any orders issued under the Law.
- Knowledge of the legislation and regulation in Jersey relating to Money Laundering and Financing of terrorism, including the Anti Money Laundering (AML), Countering the Financing of Terrorism (CFT), and Countering Proliferation Financing (CPF) Codes of practice issued under the supervisory bodies law for Trust Company Business, Fund Service Business, Alternative Investment Funds, and Certified Funds.
- The relevant Handbooks for the Prevention and Detection of Money Laundering, the Financing of Terrorism and the countering of Proliferation Financing.
- You must have an awareness of your personal obligations and those of the relevant persons under the laws mentioned above as well as the Terrorism Law, the Directions Law, Terrorist Sanctions Measures
What you will get in return:
- A genuinely unique opportunity to be part of an expanding large global business;
- Competitive remuneration commensurate with skills and experience.
- Training and development opportunities
Disclaimer: Unsolicited CVs sent to Apex (Talent Acquisition Team or Hiring Managers) by recruitment agencies will not be accepted for this position. Apex operates a direct sourcing model and where agency assistance is required, the Talent Acquisition team will engage directly with our exclusive recruitment partners.
Associate Regulatory Compliance Analyst
Posted today
Job Viewed
Job Description
Make an impact with NTT DATA
Join a company that is pushing the boundaries of what is possible. We are renowned for our technical excellence and leading innovations, and for making a difference to our clients and society. Our workplace embraces diversity and inclusion – it's a place where you can grow, belong and thrive.
Your day at NTT DATA
The Associate Regulatory Compliance Analyst is an entry level role, responsible for playing a support role in the organization's efforts to comply with various international and/or regional laws, regulations, and industry standards relevant to the IT sector.
This role provides valuable assistance to the broader regulatory compliance team and gains practical experience in regulatory compliance activities.
This role supports with research and monitoring activities and assists in the development and implementation of regulatory compliance policies, procedures and processes.
An Associate Regulatory Compliance Analyst is instrumental in assisting the company with adhering to regulatory requirements and industry standards, ensuring that it operates within the bounds of applicable laws and regulations while minimizing legal risks and promoting ethical conduct.
This role works under the supervision of a manager or more experienced team member.
Key responsibilities:
- Conducts research on global and regional laws, regulations, and industry standards affecting the IT industry.
- Stays updated on regulatory changes and their potential impact on the company.
- Assists in the preparation and maintenance of compliance documentation and reports for internal and external stakeholders (may include regulatory filings, audit reports, and compliance records).
- Supports compliance monitoring activities by assisting in tracking compliance initiatives, conducting basic internal audits, and ensuring documentation is up to date.
- Assists in the review and updating of compliance policies, procedures, and guidelines to ensure alignment with legal and regulatory requirements.
- Maintains accurate records and databases related to compliance activities, including compliance training records and incident logs.
- Participates in compliance training programs to develop an understanding of compliance standards, regulations, and best practices.
- Contributes to the identification of potential compliance risks and vulnerabilities.
- Assists in the development of mitigation plans to cover potential risks and vulnerabilities.
- Assists in reviewing contracts, agreements, and partnerships for compliance with legal and regulatory obligations, focusing on basic contract terms.
To thrive in this role, you need to have:
- Familiarity with legal and regulatory frameworks relevant to the IT industry, including data protection laws, export controls, and industry-specific regulations.
- Analytical skills to interpret and apply complex legal and regulatory requirements.
- Effective written and verbal communication skills to convey compliance information to team members and stakeholders.
- Attention to detail to ensure accurate documentation and adherence to compliance standards.
- Ability to collaborate effectively with cross-functional teams and stakeholders.
- Aptitude for identifying compliance challenges and proposing potential solutions.
- Possesses high ethical standards and integrity, with a commitment to promoting a culture of compliance and ethics.
- Has data analysis skills to assist in compliance monitoring and reporting.
- Ability to work independently or as part of a team.
- Has organizational and time management skills, together with effective planning and problem-solving skills.
Academic qualifications and certifications:
- Bachelor's degree or equivalent in law, business, compliance, or a related field.
- Relevant certifications in compliance, such as Certified Compliance and Ethics Professional (CCEP), Certified Information Systems Security Professional (CISSP), or Certified Regulatory Compliance Manager (CRCM).
Required experience:
- Entry level of knowledge of relevant laws and regulations, including data protection laws, antitrust regulations, export controls, and industry-specific regulations.
- Entry level of experience in compliance, legal, or regulatory roles within the IT industry or a related field.
- Entry level of experience with compliance auditing, reporting, and documentation.
- Entry level of experience working within a global matrixed organization, preferably within the IT services industry.
Workplace type:
Hybrid Working
About NTT DATA
NTT DATA is a $30+ billion trusted global innovator of business and technology services. We serve 75% of the Fortune Global 100 and are committed to helping clients innovate, optimize and transform for long-term success. We invest over $3.6 billion each year in R&D to help organizations and society move confidently and sustainably into the digital future. As a Global Top Employer, we have diverse experts in more than 50 countries and a robust partner ecosystem of established and start-up companies. Our services include business and technology consulting, data and artificial intelligence, industry solutions, as well as the development, implementation and management of applications, infrastructure, and connectivity. We are also one of the leading providers of digital and AI infrastructure in the world. NTT DATA is part of NTT Group and headquartered in Tokyo.
Equal Opportunity Employer
NTT DATA is proud to be an Equal Opportunity Employer with a global culture that embraces diversity. We are committed to providing an environment free of unfair discrimination and harassment. We do not discriminate based on age, race, colour, gender, sexual orientation, religion, nationality, disability, pregnancy, marital status, veteran status, or any other protected category. Join our growing global team and accelerate your career with us. Apply today.
Be The First To Know
About the latest Regulatory affairs specialist Jobs in South Africa !
Senior Legal Counsel: Regulatory, Compliance
Posted today
Job Viewed
Job Description
It's fun to work in a company where people truly BELIEVE in what they're doing
As Senior Legal Counsel, you will be responsible for providing strategic legal support to the Tiger Group Legal Team across regulatory advisory, compliance, litigation, and intellectual property matters. You will guide internal stakeholders on the implementation, execution, and monitoring of relevant legal and regulatory frameworks, ensuring alignment with South African and industry-specific legislation and industry standards. Under the supervision of the General Counsel, you will deliver efficient transactional legal services, manage legal risks, and contribute to the development of a strong governance and compliance culture. Your role will also include advising on advertising and marketing law, protecting and commercialising intellectual property assets, and supporting dispute resolution processes
What You Will Do
- Provide strategic legal advice across regulatory, compliance, litigation, and commercial matters.
- Conduct legal risk assessments and develop mitigation strategies in collaboration with internal stakeholders.
- Draft, review, and negotiate a wide range of commercial contracts and legal documentation.
- Advise on Intellectual Property matters, including protection, enforcement, licensing, and commercialisation of IP assets.
- Ensure compliance with advertising and marketing laws, including consumer protection regulations and industry codes.
- Monitor and interpret new and proposed legislation, assessing its impact on business operations and advising on necessary actions.
- Communicate legal developments and regulatory changes to relevant stakeholders with strategic recommendations.
- Support dispute resolution and litigation processes, including managing external counsel where necessary.
- Collaborate with internal teams to embed a culture of compliance and governance.
- Participate in industry forums and legal networks to stay abreast of emerging legal trends and best practices.
- Provide training and guidance to business units on legal and regulatory requirements.
- Continuously solicit feedback to improve legal service delivery and client satisfaction.
What You Will Bring To The Table
Competencies
- Strong understanding of South African & industry specific legal and regulatory frameworks.
- Expertise in Intellectual Property law, including protection, enforcement, and commercialization of IP assets.
- Solid grasp of advertising and marketing law, including regulatory compliance with consumer protection and industry standards.
- Ability to conduct regulatory assessments and interpret legislative impact on business operations.
- Skilled in legal research, risk analysis, and stakeholder engagement.
- Effective project management and task execution.
- High attention to detail and commitment to quality.
- Collaborative mindset with the ability to act as a trusted advisor.
Experience
- 4–5 years post-qualification experience (preferably in-house), ideally within FMCG or a similar industry.
- Generalist legal experience across Intellectual Property, Commercial Litigation, and Regulatory matters.
- Compliance experience is advantageous but not essential.
Qualification
- LLB degree (Bachelor of Laws)
- Admitted Attorney of the High Court of South Africa
- LLM in Business/Commercial Law (advantageous)
In accordance with the employment equity plan of Tiger Brands and its employment equity goals and targets, preference may be given, but is not limited, to candidates from under-represented designated groups.
Senior Technology Regulatory Compliance Analyst
Posted today
Job Viewed
Job Description
Want to do the Best Work of Your Life?
Working at Signant Health puts you at the very heart of the world's most exciting sector - a high-growth, dynamic company in an extraordinary industry. We're radically changing the clinical trial landscape, driving change through the technology and innovations we create and the services we deliver to our customers.
Where do you fit in?
The Senior Technology Regulatory Compliance Analyst is responsible for ensuring compliance with global regulatory standards across Signant Health's technology functions, including Enterprise IT, Cloud Operations, and R&D. Based in South Africa, this role provides leadership and expertise in regulatory compliance, focusing on systems and processes that support internally developed software products sold within the life sciences industry and Enterprise IT solutions. Reporting to the Associate Director of Regulatory Compliance, this position collaborates with cross-functional teams to build and maintain robust compliance frameworks.
Key Responsibilities:
Regulatory Compliance Oversight:
- Lead compliance efforts for technology functions to ensure adherence to global regulatory standards, including FDA 21 CFR Part 11, GAMP 5, ICH GCP, and EMA guidelines.
- Develop, implement, and maintain compliance frameworks for Enterprise IT, Cloud Operations, and R&D.
- Provide expert advice on regulatory requirements during the development and deployment of software products.
- Ensure software products meet global regulatory requirements applicable to the life sciences industry.
Audit and Risk Management:
- Plan and lead internal audits of IT systems and processes to assess compliance readiness.
- Support external audits and inspections by regulatory authorities and customers.
- Conduct risk assessments, identify potential compliance gaps, and oversee the implementation of mitigation strategies.
Policy and Documentation Management:
- Develop, review, and update policies, SOPs, and other documentation to align with regulatory requirements.
- Ensure validation and verification processes for IT systems and software are adequately documented and maintained.
Collaboration and Cross-Functional Engagement:
- Collaborate with Enterprise IT, Cloud Operations, and R&D teams to embed compliance into system design, software development, and operations.
- Act as a liaison with external stakeholders, including auditors and regulatory bodies, to address compliance-related queries.
Training and Mentorship:
- Design and deliver training programs on regulatory compliance requirements for technology teams in India.
- Mentor and guide junior analysts to ensure consistent application of compliance principles.
Continuous Improvement:
- Drive continuous improvement initiatives to enhance compliance processes and frameworks across technology functions.
- Stay updated on emerging trends and regulatory changes impacting the life sciences and software development industries.
Qualifications:
Education:
- Bachelor's degree in Information Technology, Computer Science, Regulatory Affairs, or a related field.
- Advanced degree or certifications (e.g., RAC, CRCP, or equivalent) preferred.
Experience:
- 5-10 years of experience in IT regulatory compliance, particularly in life sciences or software development.
- Strong experience with global regulatory frameworks, including FDA 21 CFR Part 11, GAMP 5, and ICH GCP.
Skills and Competencies:
- Comprehensive understanding of IT systems, cloud operations, and software development lifecycle (SDLC).
- Proven ability to manage audits and regulatory inspections with strong problem-solving skills.
- Excellent project management, communication, and leadership abilities.
- Experience in working with geographically dispersed teams and global stakeholders.
Preferred Qualifications:
- Familiarity with Agile and DevOps methodologies.
- Experience with compliance in cloud-based environments and data security standards.
Does this sound like
you'd like to explore
? Then we'd love to hear from you
Please apply below.
We review and respond to every application, keep an eye on your inbox for our reply.
Please note that Signant does not accept unsolicited resumes from Third Party vendors.
Regulatory and Compliance Specialist
Posted 1 day ago
Job Viewed
Job Description
- Bachelor's degree in the field of regulatory/ compliance/ risk specialization or
- BSc or Bachelor in Technology (Chemistry/Engineering)
- At least 5 years experience as a regulatory compliance specialist, or similar
- 5 10 years in a chemical manufacturing plant or related process manufacturing industry.
- Must have a strong regulatory and compliance background.
- Advanced knowledge and understanding of relevant corporate governance requirements and South African Regulatory Requirements in related industries.
- Knowledge of product regulations pertaining to NSF, FDA, Halaal, Kosher, BfR, REACH, Food Safety etc.
- Advanced understanding of relevant legislation and standards (non-proliferation of explosive material, regulatory, Occupational Health and Safety Act (Act 85 of 1993), ISO 9001:2015, 14001:2015 and 45001:2018).
- Advanced understanding the Globally Harmonised System (GHS) related to (SDS, label and tremcard development, generation and other legal requirements).
- Advanced understanding of information systems that generate SDS, label and tremcards
- Good knowledge of chemical technologies Chemistry and Chemical Engineering
Duties:
- Ensuring that products are developed, manufactured and distributed in a manner that meets regulatory requirements.
- Manage/conduct internal and external compliance audits aligned to registrations, local, corporate and Legal requirements.
- Managing information systems that develops and generate regulatory documents.
- Coordinating regulatory compliance requirements across the organizational structures.
- Monitoring compliance and facilitating interventions to manage risks.
- Developing and enacting regulatory compliance policies, procedures and strategies.
- Providing training in regulatory and compliance practices and procedures.
- Incident Management/Non- Conformances related to regulatory compliance.
- Keeping abreast of local and international regulatory changes, developments and impacts on Buckman's business.
- Consultation and Communication with Stakeholders
- Managing associated day-to-day expenses
- Support compliance to and minimize our risk as per the POPIA legislative requirements.
- Initiate and implement continuous improvement.
- Providing support for the generation of Safety Data Sheets (SDS), label and tremcard development.
- The incumbent in this position is key to the companys succession planning and may be given other assignments as part of ongoing developmental efforts.
If you have not heard from us within 3 months of applying, please consider your application unsuccessful.
Only online applications will be considered.
You will be directed to our database service provider, Ditto Jobs. Please complete your application in full. Shortlisted candidates will be contacted. Should any other suitable positions become available, Elchemie will contact you to request your permission to submit your profile to a client.
By submitting your application, you give consent and authorise Elchemie to undertake collection, processing, and further processing of your Personal Information for the purposes of potentially securing employment.
As an applicant you agree to make available to Elchemie all necessary personal information required for the purpose of potentially securing employment and you understand and agree that should you upload personal information and data, that information will be shared with our authorised job placement database service provider, job portals, and -websites, where such an advert is managed by our services and service providers.