Regulatory Affairs Specialist Job Vacancy in Salima, Malawi – Pharmaceuticals

Job Description

Position:Regulatory Affairs Specialist

Company:GlaxoSmithKline Malawi

Location:Salima, Malawi

Experience:5+ years in regulatory affairs within pharmaceutical industry

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

Employment Type:Full-time

Industry:Pharmaceuticals

Department:Regulatory Affairs

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

Vacancies:1

Company Overview

GlaxoSmithKline Malawi is a leading global healthcare company dedicated to improving the health and well‑being of people across the nation. With a strong presence in Malawi for over two decades, GSK combines innovative research, high‑quality medicines, and a commitment to community health initiatives. Our operations in Salima focus on manufacturing, distribution, and regulatory compliance, ensuring that life‑saving medicines reach every corner of the country. As part of our mission, we continuously seek talented professionals who share our passion for excellence and ethical standards.

Joining GSK Malawi means becoming part of a diverse, inclusive, and forward‑thinking team that values integrity, collaboration, and continuous learning. We are proud to contribute to Malawi Jobs, offering career opportunities that empower individuals and support national development.

Job Overview

The Regulatory Affairs Specialist will lead the preparation, submission, and maintenance of all regulatory dossiers for pharmaceutical products marketed in Malawi. This role ensures compliance with local and international regulations, liaises with the Malawi Pharmacy and Medicines Regulatory Authority (PMRA), and supports cross‑functional teams in product development and launch. The specialist will also monitor regulatory changes, provide strategic guidance, and act as the primary point of contact for all regulatory matters.

For more information about our company and culture, visit our main website at https://malawijobsearch.com/. This position offers a unique platform to influence health outcomes while advancing your career in a dynamic environment.

Key Responsibilities

• Prepare, review, and submit regulatory applications, amendments, and renewals for all pharmaceutical products.
• Maintain up‑to‑date regulatory dossiers and ensure accurate documentation in compliance with PMRA guidelines.
• Monitor and interpret local and international regulatory changes, advising internal teams on impact and required actions.
• Collaborate with R&D, Quality Assurance, and Marketing to ensure regulatory requirements are integrated throughout product lifecycle.
• Serve as the primary liaison with the PMRA, handling inspections, queries, and correspondence.
• Develop and implement regulatory strategies to accelerate product approvals and market entry.
• Provide training and guidance to staff on regulatory best practices and compliance.

Required Skills

• In‑depth knowledge of Malawi pharmaceutical regulations and international guidelines (ICH, WHO).
• Strong analytical and problem‑solving abilities.
• Excellent written and verbal communication skills.
• Proficiency in regulatory submission software and document management systems.
• Ability to work cross‑functionally and manage multiple projects simultaneously.
• Attention to detail and high level of organizational skills.

Education

A Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. A Master’s degree or professional certification in Regulatory Affairs (e.g., RAC) is highly desirable.

Experience

Minimum of five years’ experience in regulatory affairs within the pharmaceutical industry, with a proven track record of successful product submissions and approvals in African markets.

Salary

The position offers a competitive salary range of SSP 1,200,000 to SSP 1,800,000 per month, commensurate with experience and qualifications, along with performance‑based incentives.

Benefits

• Comprehensive health insurance for employee and dependents.
• Retirement savings plan.
• Paid annual leave and sick leave.
• Professional development allowance.
• Employee assistance program.

Training

• On‑boarding program covering GSK policies, compliance, and local regulations.
• Continuous learning opportunities through internal GSK academies and external workshops.
• Mentorship from senior regulatory leaders.

Working Environment

Our Salima office provides a modern, collaborative workspace equipped with the latest technology. Employees enjoy a supportive culture that encourages innovation, work‑life balance, and community engagement. GSK Malawi promotes a safe and inclusive environment where every voice is valued.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their suitability for the role through our online portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for interviews.

Equal Opportunity Statement

GlaxoSmithKline Malawi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, age, disability, or sexual orientation. We encourage qualified individuals from all backgrounds to apply for this exciting opportunity.