26 Legal And Regulatory Frameworks jobs in South Africa

Company Description

Established in 1987 and headquartered in South Africa, Southern Implants is a leading provider of innovative dental implant products aimed at top-end professional users seeking more choices. The company's expertise in research, development, and manufacturing enables them to offer innovative treatment solutions that reduce treatment times and improve patient outcomes. Southern Implants is committed to providing the highest level of technical support through its global network of professional representatives. With a continually expanding product range, Southern Implants stays ahead of the newest technologies and trends to complement clinicians in delivering superior care standards to their patients and referral base.

Role Description

This is a full-time, on-site role located in Pretoria for a Regulatory Affairs & Quality Manager. The Regulatory Affairs & Quality Manager will be responsible for ensuring compliance with all regulatory requirements, managing the company's quality management system, preparing and submitting regulatory documents, maintaining technical files, and liaising with regulatory bodies. The role also involves conducting internal audits, overseeing product labeling, and ensuring that the company's products meet the highest standards of quality and safety.

Qualifications

• Experience in Regulatory Affairs and Quality Management
• Strong understanding of regulatory requirements and standards for medical devices
• Proficiency in preparing and submitting regulatory documents
• Skills in conducting internal audits and managing quality management systems
• Excellent written and verbal communication skills
• Strong leadership ability
• Attention to detail and strong organizational skills
• Ability to work on-site in Pretoria
• Bachelor's degree in a scientific, technical, or related field
• Experience in the dental or medical device industry is a plus

At
I&J
, part of
AVI
, we combine close to 115 years of excellence with a forward-thinking approach to the fishing industry. As a leader in premium seafood, including Cape Hake and farmed Cape Abalone, we are committed to sustainability, innovation, and empowering local communities. Our latest innovation, Air-Fri'kn Amazing, brings bold flavours and crispy perfection to your air fryer, showcasing our passion for quality and customer-centric excellence.

Why Join I&J?

• Industry Leader: Work with a renowned brand known for premium Cape Hake and farmed Abalone.
• Sustainability Focused: Contribute to responsible fishing practices with MSC accreditation.
• Community Impact: Be part of a company that empowers and invests in local communities.

An exciting opportunity exists for a
REGULATORY AFFAIRS COORDINATOR
at
I&J, Head Office
to be based in
Woodstock, Cape Town
. The purpose of this role is to ensure all I&J products produced or co-packed are legally compliant with all current International and Domestic Regulations. To also proactively form part of the relevant industry groups to limit regulatory risks to I&J as far as possible.

Reporting Structure

• Reports to: Senior Research and Development Manager

Key Areas Of Impact
Compliancy to International and Domestic Regulations

• Ensure all I&J products that are produced and purchased are compliant with all current International and Local regulations as well as mandatory and voluntary information including claims & endorsements.
• Ensuring all labelling requirements are met irrespective of country of designation.
• Ensuring I&J products are produced according to the relevant standards and regulations.
• Issue necessary guidelines to the Research and Development (R&D) and Marketing Teams alike.

Product Development In Terms Of Regulatory Requirements And Compliancy

• Generating all ingredient declarations for the various products.
• Assists with completing Customer Specifications and ensuring they align with I&J specifications.
• Liaise with relevant accreditation bodies like Halaal, Beth Din, MSC, FOPL, ASC and more.
• Provides PDF copies of final product specifications when requested and if approved by Snr R&D Manager.
• Take ownership of the projects allocated to the Regulatory portfolio for example, actively manage and take accountability.

Management and coordination of Research and Development Quality Manual

• Oversee the management of R&D Quality Manual and ensure R&D is updated & compliant with the latest versions of International Food Safety (IFS) and British Retail Consortium (BRC) certifications
• Manage and co-ordinate internal audits of the R&D department
• Act as representative for R&D on the I&J HACCP Management Team.
• Assist the Quality Assurance (QA) Team with internal audits when necessary.
• Ensuring all retail products are sent for nutritional analysis every 3 years.
• Ensuring GMO Free and any other relevant tests are completed as well as ensuring products are screened when required.
• Analysis: Maintenance of the Lab analysis cost spreadsheet of all products sent away for analysis.
• Vulnerability assessments: Keeping abreast of fraudulent, mislabeling and substitution occurrences for raw materials and ingredients by accessing various websites and subscribing to alerts.
• Conducts an annual Vulnerability Assessment review of all raw materials and ingredients together with Q.A., Procurement and Supplier Quality Assurance Departments.

Staying abreast of new regulatory and scientific issues impacting business

• Keeping abreast of international and local legislation, guidelines, and customer practices.
• Escalating issues that may impact the I&J business to the Senior R&D Manager. Assist management to escalate issues through to the relevant local and global forums.
• Issue Regulatory Guidelines which will have an impact on the I&J business.
• Train the R&D and Marketing Teams on new legislation and inform the Quality Assurance department of new or amended regulations.

Proactively form part of relevant Industry Groups

• Attend CGCSA FSI meetings and actively participate in working groups relating to the I&J business.
• SAMPA (SA meat processing association), attend the Annual General meeting.
• Keep informed of the working groups for relevant SA Legislation - Voluntary Standards and Compulsory Standards.
• Attend new local labelling regulations work groups.

What It Takes To Succeed
Experience that set you up for success:

• Minimum 5 years in a similar role within a food processing environment with regulatory experience

Qualifications & Certifications That Will Contribute To Your Success

• Grade 12 / Matric
• National Higher Diploma in Food Technology or BSc Food Science qualification

Additional Requirements That Will Enhance Your Impact For Success

• Experience of HACCP for Processors
• Completed IFS and BRC Training
• Understanding of ISO V5.1
• Available to work overtime when need be
• Own reliable transport

Take the Next Step with I&J
Join us to shape the future of South African seafood while making a meaningful impact on communities and the environment and be part of a team committed to excellence and making a positive impact.

KEY RESPONSIBILITIES

Product registration

• Conduct due diligence on new dossiers from overseas and local suppliers and compile for submission as and when required in neighbouring countries
• Compile and submit new registration applications, variations and renewals in neighbouring countries in line with South African dossiers.
• Conduct due diligence on received change controls, variation packages, and dossiers
• pertinent to, but not restricted to, lifecycle management of the assigned product portfolio in neighbouring countries
• Compile and submit responses to pre-registration recommendations, safety updates, renewals and variations, within agreed and specified time limits.
• Liaise with Regulators on behalf of the division on new and existing queries as and when required.
• Identify and maintain updates on existing products based on guidelines and allocated priorities in neighbouring countries
• Interact on a regular basis with PD departments, overseas affiliates, third parties and
• contractors on dossier related activities.
• Assist with the registration process and commercialisation of Complementary products in consumer portfolio
• Update the SAHPRA CAMS licence (3D-licence) when required – New CAMS products or changes to existing products
• Maintain the department's online apps (CCP database, docuBridge, Artwork app) as per official SOPs and/or working instructions.
• Assistance with the artwork process to finalise printed packaging components in submitted countries in line with Regulations
• Interact with Third-Party Suppliers on dossier related activities (supplier meetings)
• Provide regulatory advice to internal and external stakeholders when required

Technical activities

• Assist department as a Power User (PU) for docuBridge, including, but not limited to, assisting with dB monthly report, validation errors, training, inclusion of new variations/products in dB monthly
• Compile and control permit process applications
• Assists with review of clinical questionnaires from Marketing department
• Manage and monitor the Change Control Process effectively

General

• Perform any other duties as per changes in operational requirements of the department.
• Perform any other duties as requested.

PRE-REQUISITES

• B. Pharm.
• Minimum of 1-2 years Regulatory hands-on experience, preferably within the pharmaceutical industry.
• Able to perform all standard registration processes under specialist guidance.

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.

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Regulatory Affairs Pharmacist

Active registration with SAPC is mandatory.

SAHPRA experience: Must have personal, hands-on experience in/be knowledgeable on:

• conducting due diligence (gap analysis) and advising on the feasibility of registration potential of a new product dossier.

• preparing and submitting eCTD dossier sequences (including preparing country specific documents) as applicable to new applications for registration, quality and clinical variations, baselines, responses to queries, including associated tasks, for example e-CTD validation (and fixing validation errors), liaising manufacturers, laboratories to obtain necessary information etc.

• the requirements to register and manage the lifecycle of generic medicines and extension applications. Experience with biological medicines will be an advantageous (new registrations and variations). Knowledge on previously accepted dossier formats (like paper CTD, e-submission, MRF) will be advantageous.

• Experience with other regulatory authorities such as NMRC, ZAZIBONA, BoMRA etc. would be advantageous.

Must be able to work in a team towards a common goal (i.e. RA department and company as a whole), but otherwise capable to run with a project in own personal capacity.

Willing to act as a deputy RP will be an advantage.

Must be based in Cape Town and have a reliable car to travel to/from work and be punctual (office based in Century City).

Job Types: Full-time, Permanent

Work Location: In person

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

BIOVAC
is one of the leading sterile vaccine manufacturers rooted in Africa, with our core purpose being to "protect life". We are looking to hire a dynamic, passionate, confident, proactive and meticulous
Regulatory Affairs Pharmacist
to join a goal-oriented team.

Qualifications Needed

• Bachelors degree in pharmacy
• Pharmacist registration with SAPC

Necessary Experience & Industry Knowledge

• 5 years related experience in vaccine / biotech / pharmaceutical industry or equivalent
• Thorough knowledge of the current Medicines and Related Substances Act 101 and the Pharmacy Act 57 and current regulatory policies and guidelines of SAHPRA and their implication to the company.
• Experience in Pharmaceutical Regulatory Affairs aspects (Medicine registration and legal compliance) and documentation management and product maintenance related to the product portfolio
• Experience in quality and regulatory compliance within a cGMP facility.
• Program and project management
• Experience in registering product in ZAZIBONA /EAC-AMRH
• Experience in having faced successfully local and/ or international quality audits.
• Experience in eCTD compilation

Core Technical Delivery
KEY DUTIES & RESPONSIBILITIES OF THE ROLE:

• Maintenance and monitoring of existing registration dossiers (amendments and updates) including timeous responses to resolutions from NRAs by receiving and submitting all applicable updates, post-registration amendments, resolutions and any other correspondence required by the SAHPRA or any other applicable regulatory authority in accordance with current guidelines and within the specified timelines in order to support the strategic business objectives and close any compliance gaps as quickly as possible.
• Preparing and submitting post-registration clinical updates to package inserts and patient information leaflets in line with current SAHPRA guidelines and regulations.
• Perform due diligence audits of existing and new product regulatory dossiers.
• Author, compile, publish and submit new registration dossiers to NRAs in the required format for local (SA) and identified export markets for new products and when applicable work in conjunction with consultants to achieve submission.
• Completion of applicable Section 36 Exemption, Section 21 and Clinical Trial Applications.
• Update and maintain dossiers to latest requirements
• Identify key opportunities and deliverables as required by the department or by other departments for cross functional synergies/ project work.
• Provides regulatory advice when required to relevant stakeholders including sales, marketing, supply chain, medical and commercial team with regards to the products.
• Assist RA HOD in follow ups / responses on regulatory audits by third party / NRA
• Regulatory Intelligence: Assist RA HOD to Identify anticipated risks impacting department/ section/ team / keeping business abreast of regulatory developments, trends) and changes in the local regulatory and international environment which directly impacts Biovac products. Effectively communicating these changes so that all relevant stakeholders may assess the impact on the business.
• Request and obtain Import & Export Permits
• Writing / Reviewing and / updating of Regulatory SOPs (comprehensive and up to date and revised as per internal plan)
• Assist and or provide guidance in opening and close out of delegated Change Controls/ NCRs / CAPAs in order to support QAs processes.
• Review and approve artwork for packaging material to ensure compliance with regulatory requirements.
• Maintain and establish relationships with the SAHPRA units and/or other Health Authorities to ensure more effective streamlining of the companys applications when required
• Ensure that the Document Database is kept in good order by completing the required administrative activities for appropriate maintenance, co-ordination and accuracy of all dossiers and correspondence
• Approve promotional material (advertising)
• Assist in establishing the annual regulatory budget

Application Deadline: 15 August 2025
If you do not receive a response from us within three weeks of submitting your application, please understand that your application was not successful.

We believe in the magic of diversity within teams and to achieve this, we do apply Employment Equity principles during our selection process where this is necessary to achieve such diversity.

Disclaimer
Dear Applicant, we appreciate your interest in joining our organisation. It is imperative for us that you understand how we handle your information. We are committed to ensuring the security and confidentiality of the information you provide. Your personal details will be collected for the sole purpose of the application process and will be used strictly for that purpose. By applying, you acknowledge and consent to the collection, use, and protection of your personal information in accordance with our privacy policy. If you have any inquiries or concerns, our Human Capital department is available to provide clarification. We look forward to reviewing your application.

Fresenius Kabi is a global healthcare company more than 40,500 employees worldwide.

We are dedicated to a higher purpose "caring for life" which drives excellence in everything we do.

The manufacturing plant in Port Elizabeth produces both small and large volume parenterals.

The main purpose of the Regulatory Affairs Pharmacist to prepare and submit medicine registration applications to various regulatory authorities outside South Africa in accordance with regulatory requirements of the relevant country. To maintain these registration applications subsequent to registration approval.

General Duties:

• Preparing and submitting medicine registration applications for imported and locally made products in foreign countries.
• Maintaining existing product registrations in foreign countries.
• Responding to any deficiency letters or requests for information from the foreign countries.
• Checking of printed packaging specifications and proofs relevant to these registrations.
• Provision of product registration information on request by the Site Responsible Pharmacist and Export Marketing Managers.
• Assisting the Export Marketing Department with tender information relevant to the company.
• Preparing documents for international company registration in various territories.
• Maintaining the international registration product list.
• Assist with Batch Release when necessary

• From time to time, carry out other jobs within the factory /department, consistent with the grade qualification and training of the incumbent.

• B. Pharm / Dip. Pharm.

• Registered Pharmacist with South African Pharmacy Council.
• 2-5 years Industrial Pharmaceutical Regulatory Affairs experience
• GMP, GWP and GDP Principles
• Understand quality investigation requirements (risk assessments, deviations, OOS, change controls)

Primary Functions:

The Regulatory Affairs Assistant of the Quality Assurance Department has the following responsibilities:

• To assist with documentation as required.
• Confirming the correctness of text on all printed components used in the company before approval
• To send all approved artwork to the brand owner and approvals to printers.
• Prepare any regulatory applications, amendments and master documents to provide compliance with the relevant applicable standards.
• To prepare technical files for all packed products.
• ·Assist QA Supervisor in the preparation of all master documents to provide for the production/packaging, supply and use of the correct starting and packaging materials and production of finished products.
• Participate in performing audits
• Updating of the Standard Operating Procedures Appendix list and saving SOPs onto the server as PDF documents
• Keeping a database for the master SOPs in Word format as well as superseded SOPs
• Updating and assisting in the updating of quality-related SOPs
• Updating of Training Matrix and training needs/requirements for staff, as well as retaining the training record files
• Assist QA Supervisor in data trend analysis for temperature monitoring, product stability and other quality KPIs.
• To verify and sign that information on packing documents is correct according to the server.
• To enter all part passes, mixed batch and released goods on the Batching folder on the server.
• To assist the QA Supervisor in handling the personal protective garments of staff in respect of timeous receipt, and ensure that all queries lodged are followed up.
• To ensure the pest control contractor has been to all necessary areas and all findings are documented.
• To update when necessary, the internal audit schedule
• Assist the QA Supervisor in maintaining the Equipment Calibration schedule.
• To assist in Quality checks on production lines if required.
• Assist in any duties that may be assigned by management.

Ideal Candidate Requirements:

·   Computer literacy – Thorough knowledge of Word, Excel, and Outlook is critical

·   Experience with SYSPRO/ similar ERP system

·   Prior related experience in the QA field is advantageous

·   Willingness to multitask

·   Willing to take on additional responsibilities

ALL INTERESTED CANDIDATES PLEASE SEND C.V. DIRECTLY TO SAGRIE, OR EMAIL TO BY 15 SEPTEMBER 2025.

INTERVIEWS WITH SHORTLISTED CANDIDATES ONLY WILL TAKE PLACE THEREAFTER.