Regulatory Affairs Manager Job Vacancy in Mangochi, Malawi – Pharmaceuticals

Job Description

Position: Regulatory Affairs Manager

Company: GlaxoSmithKline Malawi

Location: Mangochi, Malawi

Experience: Minimum 5 years in pharmaceutical regulatory affairs

Education: Bachelor’s degree in Pharmacy, Life Sciences or related field; Master’s preferred

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 1,200,000 – SSP 1,800,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline (GSK) Malawi is a leading multinational pharmaceutical company dedicated to improving health outcomes across the region. With a strong presence in Malawi for over two decades, GSK Malawi operates state‑of‑the‑art manufacturing facilities, a robust distribution network, and a commitment to research and development that aligns with global standards. The company’s mission is to innovate, develop, and deliver high‑quality medicines, vaccines, and consumer health products that address the unique health challenges faced by Malawians. As part of GSK’s global family, the Mangochi office plays a pivotal role in regulatory compliance, market access, and stakeholder engagement, offering a dynamic environment for professionals seeking to make a tangible impact on public health. This is an excellent opportunity for ambitious individuals to join a reputable organization that values integrity, collaboration, and continuous learning. The role contributes directly to GSK’s vision of helping people do more, feel better, and live longer, reinforcing the company’s reputation as a trusted partner in the healthcare ecosystem of Malawi.

For more information about GSK’s global initiatives, visit https://malawijobsearch.com.

Job Overview

The Regulatory Affairs Manager will lead the regulatory strategy for all pharmaceutical products marketed by GSK Malawi, ensuring compliance with local and international guidelines. This role involves close collaboration with cross‑functional teams, including Quality Assurance, Clinical Development, Marketing, and Legal, to navigate the complex regulatory landscape of Malawi and the Southern African Development Community (SADC). The manager will be responsible for preparing and submitting dossiers, maintaining product registrations, and providing strategic advice on regulatory implications of new product launches and lifecycle management. The position offers a unique platform to influence health outcomes, drive market access, and uphold the highest standards of product safety and efficacy. As part of the regulatory affairs department, the manager will also mentor junior staff, foster relationships with the Malawi Pharmacy and Medicines Regulatory Authority (PMRA), and stay abreast of evolving regulations to ensure proactive compliance.

Explore regional career opportunities at https://southafricajobsearch.com/job-vacancy-in-south-africa/.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations, variations, and renewals in Malawi.
• Prepare, review, and submit comprehensive regulatory dossiers, including INDs, NDAs, and MAA applications.
• Liaise with the Malawi Pharmacy and Medicines Regulatory Authority (PMRA) to ensure timely approvals and address queries.
• Provide regulatory guidance to R&D, manufacturing, and commercial teams throughout product lifecycle.
• Monitor changes in local and international regulations, assess impact, and implement necessary updates.
• Maintain an up‑to‑date regulatory intelligence database and ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards.
• Lead internal audits and support external inspections related to regulatory affairs.
• Mentor and develop junior regulatory staff, fostering a culture of continuous improvement.

Required Skills

• In‑depth knowledge of Malawi’s pharmaceutical regulations and SADC harmonized guidelines.
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills for drafting dossiers and interacting with authorities.
• Proven project management skills, capable of handling multiple submissions simultaneously.
• Ability to work collaboratively across multidisciplinary teams and influence decision‑making.
• Proficiency in regulatory software tools and Microsoft Office Suite.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life‑science discipline is required. A Master’s degree or professional certification (e.g., RAC, RAPS) is highly desirable and will be considered an advantage during the selection process.

Experience

Minimum of five (5) years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local and international submissions. Experience in managing product registrations in emerging markets and a track record of successful interactions with regulatory authorities are essential.

Salary

The competitive salary range for this position is SSP 1,200,000 to SSP 1,800,000 per month, commensurate with experience and qualifications. Performance‑based incentives and annual reviews are part of the compensation package.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid leave, including annual, sick, and parental leave.
• Professional development budget for certifications, conferences, and training.
• Employee assistance program and wellness initiatives.

Discover additional career resources at https://kenyajobsearch.com/.

Training

• Onboarding program covering GSK’s regulatory policies, systems, and compliance standards.
• Continuous learning opportunities through internal GSK Academy modules.
• Access to external workshops on regulatory updates, pharmacovigilance, and quality management.

Working Environment

GSK Malawi offers a collaborative, inclusive, and innovative workplace where diversity of thought is celebrated. The Mangochi office provides modern facilities, flexible working arrangements, and a supportive culture that encourages work‑life balance. Employees are empowered to take ownership of projects, contribute ideas, and drive meaningful change in the healthcare sector.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their suitability for the role through the GSK careers portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment. Please ensure all documents are uploaded in PDF format.

Equal Opportunity Statement

GlaxoSmithKline Malawi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.