What Regulatory Writing Jobs are in South Africa?

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
Join Us as a Manager Medical Writing - Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our expert team, you'll have the opportunity to ensure operational excellence that makes a real difference in organizational performance. As a Manager Medical Writing, you will manage the performance and workload of Medical Writers and provide short-term and long-term resource planning to assign projects to appropriate and available staff. You will supervise the preparation of Medical Writing deliverables and organize processes for the completion of projects within established timelines. You will evaluate the timeliness and quality of deliverables. You will assist writers in the presentation and interpretation of data and perform senior reviews to ensure overall adherence to departmental standards. Additionally, you will participate in the preparation and review of group SOPs and WPDs, evaluating compliance with SOP/WPD on an ongoing basis. You will give marketing presentations to potential clients on the capabilities of the Medical Writing department and interact with Bids and Contracts and Business Development to prepare budgets and proposals for Medical Writing projects. You will also participate in the development of training programs for Medical Writing and ensure direct reports are adequately trained.
What You'll Do:
- Supervises Medical Writers. Provide short-term and long-term resource planning in order to assign projects to appropriate and available staff. Holds regularly scheduled meetings with staff and provide updates to senior management. Review and approve semimonthly time sheets. Assist staff to forecast project-related costs and timelines for completion. Hires and evaluates employees. Recommends salary levels and promotions
- Supervises the preparation of Medical Writing deliverables. Organizes processes for completion of projects within established timelines. Evaluate timeliness and quality of deliverables and provides updates to senior management. Acts as resource for questions relating to study design, adverse event reporting, and statistical analyses. Assists writers in presentation and interpretation of data. Performs senior review to ensure overall adherence to departmental standards. Write and review group SOP and WPD. Evaluates compliance with SOP/WPD on an ongoing basis. Stays updated on relevant publication guidelines and requirements (GPP, ICMJE, etc.)
- Gives marketing presentations to potential clients on the capabilities of the Medical Writing department. Interacts with Bids and Contracts and Business Development to prepare proposals for Medical Writing projects.
- Develops and maintains training programs for Medical Writing. Ensures that all writers are adequately trained.
- Uses scientific knowledge to assist in the written interpretation of scientific data and to guide others in their presentation of scientific data.
Education and Experience Requirements:
- Bachelor's degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred
-Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or an equivalent combination of education, training, and experience. Minimum of 5 years of relevant experience in medical publications writing, preferably within the pharmaceutical, biotechnology, CRO, or medical communications industry. Demonstrated experience managing scientific writing staff, overseeing publication deliverables, and supporting publication planning and execution is required."
- 1+ year of leadership responsibility
Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.
Knowledge, Skills and Abilities:
- Ability to supervise, evaluate, and mentor departmental personnel
- Ability to oversee assignments, monitor staff workload, and provide guidance for completion of assignments
- Ability to create and modify project timelines, allocate resources, and forecast departmental workload
- In depth knowledge of departmental processes and ability to contribute to improving and developing processes
- Excellent medical writing skills, including excellent grammatical, editorial, and proofreading skills, and the ability to effectively interpret and present extremely complex data
- Effective communication, negotiation, and presentation skills needed to represent the department in a range of situations including bid defenses, capabilities presentations, and audits
- Ability to develop, review, and modify proposals and budgets for presentation to clients
Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.
Apply today to help us deliver tomorrow's breakthroughs.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

**Job Description Summary**
Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
**Job Description**
**Roles and Responsibilities**
+ Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
+ Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.
+ A job at this level is likely to be an individual contributor, with proven interpersonal skills. Communication with direct colleagues and the business about design and coordination services rendered. Provides informal guidance to new team members. Explains complex information to others in straightforward situations.
+ Impacts projects, processes and procedures in own field. The role operates with some autonomy, but is focused on execution of activities/provision of advice within an enabling discipline covered by standard functional practices and procedures. Activities require professional judgment, but may require more senior levels of guidance.
+ Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.
**Required Qualifications**
+ Pharmacist degree or Master's degree in a scientific discipline from an accredited university or college.
+ Significant experience in Regulatory Affairs within medical device industry, including regional or global roles.
+ Advanced knowledge of applicable regional and international regulatory frameworks and postmarket requirements.
**Desired Characteristics**
+ Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.
+ Demonstrated experience interfacing with regulatory agencies (e.g. SAHPRA, NAFDAC, BOMRA, etc.) and standards bodies such as IEC, ISO, and relevant regional bodies.
+ Experience with postmarket surveillance activities, including adverse event reporting, vigilance systems, recalls, and field safety corrective actions.
+ Strong leadership, stakeholder management, and project management skills, with the ability to prioritize and execute in a dynamic, matrixed environment.
+ Demonstrated experience working in a cross-functional environment and proven ability to influence and build consensus among multiple internal functions, external stakeholders (trade association, regulators).
**Inclusion and Diversity**
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
**Behaviors**
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership - always with unyielding integrity.
**Total Rewards**
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
\#LI-FG1
\#LI-Hybrid
**Additional Information**
**Relocation Assistance Provided:** No

**Our Purpose**
_Mastercard powers economies and empowers people in 200+ countries and territories worldwide. Together with our customers, we're helping build a sustainable economy where everyone can prosper. We support a wide range of digital payments choices, making transactions secure, simple, smart and accessible. Our technology and innovation, partnerships and networks combine to deliver a unique set of products and services that help people, businesses and governments realize their greatest potential._
**Title and Summary**
Senior Counsel, Regulatory Affairs
Overview
Mastercard's Global Regulatory team is responsible for liaising with key regulators and law enforcement officials for the purpose of preventing or minimizing the impact of adverse regulations on the company's profitability and growth potential. This position will report to the Senior Managing Counsel, Regulatory Eastern Europe Middle East Africa ("EEMEA") based in Dubai, UAE. This position is part of the Global Regulatory team from a functional perspective and EEMEA CAO (Chief Administration Office) team from a regional and global perspective.
Role
The Senior Counsel, Regulatory, South Africa based role will assist in managing regulatory matters arising in Southern Africa and related within the EEMEA region of Mastercard. This individual will:
- Support the development and execution of regulatory strategy for Southern Africa and identified business verticals within the EEMEA region
- Proactively engage with regulatory authorities to advance Mastercard's business strategy taking into consideration other related markets
- Engage on the timely submission of regulatory filings/submissions and develop responses to requests in accordance with internal policies, processes and procedures
- Guide the organization by providing regulatory advice on various matters arising in Southern Africa as well as at an EEMEA region level
- Participate in multi dimensional projects across business units/regions or globally, successfully navigating throughout the organization by partnering effectively with individuals from other departments and delivering results
- Participate in the defense of the company in proceedings or quasi- proceedings with regulators in the region
- Anticipating, evaluating and identifying Southern African (and where relevant EEMEA) regulatory risk and support the teams with assessing and implementing controls to mitigate risks
- Work in close collaboration with the EEMEA Government Affairs and Policy, PAIR (Privacy, AI and Data Responsibility) and Regional Counsel teams, including global counterparts to keep informed of regional and global developments.
All About You
- LLB or JD from an established and reputable law school
- Deep understanding of the South African and broader Southern African regulatory environment
- Fluency in English (written and spoken) is a requirement
- Excellent written and oral communication skills a must.
- Experience in a regulatory position in a corporation, association or government context and/or as a regulatory attorney in a law firm (preferably in the payments industry, banking, fintech or financial services sector)
- Knowledge of financial and/or payments systems and services regulations
- Experience in applying for regulatory licenses and managing the regulatory licenses
- Proven success in navigating multi-national organizations and operating effectively within a diverse multicultural organization
- Must demonstrate a proactive, time sensitive, results driven approach in carrying out all duties, obligations and responsibilities
**Corporate Security Responsibility**
All activities involving access to Mastercard assets, information, and networks comes with an inherent risk to the organization and, therefore, it is expected that every person working for, or on behalf of, Mastercard is responsible for information security and must:
+ Abide by Mastercard's security policies and practices;
+ Ensure the confidentiality and integrity of the information being accessed;
+ Report any suspected information security violation or breach, and
+ Complete all periodic mandatory security trainings in accordance with Mastercard's guidelines.

What youll be doing

• Ensure compliance with Act 36 of 1947 and relevant regulatory frameworks
• Oversee Quality Assurance processes across manufacturing, including batch review and product release
• Manage raw material and finished product release, ensuring full complianc e before distribution
• Support regulatory alignment across operations and communicate updates effectively
• Lead deviation investigations, CAPAs, and customer complaint resolution
• Support product development, including stability studies and trial protocols
• Ensure proper storage, handling, and distribution conditions across the supply chain
• Participate in audits, mock recalls, and continuous improvement initiatives

What youll need

• Degree in a relevant scientific field (i.e Animal Science, Agri or similar
• Experience in pharmaceutical, veterinary, or related QA/regulatory environments -ACT 36
• Working knowledge of FSSC22000, ISO9001, GMP + FSA standards
• Strong attention to detail, analytical thinking, and problem-solving ability
• Ability to work across teams and maintain high-quality documentation

What is in it for you?

• You will be joining a team committed to advancing animal health through science, quality, and innovation
• Remuneration R cash component, depending on experience and current

A Few Things to Know

• The ideal candidate will be Self-motivated, self-directed and Highly autonomous
• If you are disciplined, driven and accountable you could fit in well
• No benefits apply- cash component only

Ready to Apply?
Click Apply and please complete your application in full.
If you dont hear from us within 3 months, your application was not successful. However, we may contact you for other roles in the future (with your permission).

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