Regulatory Affairs Manager Job Vacancy in Lusaka, Zambia – Pharmaceutical Manufacturing

Job Description

Position: Regulatory Affairs Manager

Company: GlaxoSmithKline Zambia

Location: Lusaka, Zambia

Experience: 8+ 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: Pharmaceutical Manufacturing

Department: Regulatory Affairs

Salary: SSP 150,000 – 250,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline Zambia (GSK) is a leading global healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence in Zambia, GSK manufactures and distributes a wide range of essential medicines, vaccines, and consumer health products. The company is committed to innovation, ethical practices, and sustainable development, making it an attractive employer for professionals seeking meaningful impact. As part of GSK’s expansion strategy, the Lusaka facility continues to grow, offering diverse career opportunities across multiple functions. This role contributes directly to GSK’s mission of delivering high‑quality pharmaceutical solutions to the Zambian market and beyond, aligning with the broader goal of enhancing public health.

Job Overview

The Regulatory Affairs Manager will lead the regulatory strategy for all pharmaceutical products manufactured and marketed by GSK Zambia. Reporting to the Head of Regulatory Affairs, you will be responsible for ensuring compliance with local and international regulations, preparing dossiers, and liaising with the Zambia Medicines Regulatory Authority (ZAMRA) and other health agencies. This position plays a pivotal role in guiding product registrations, post‑approval changes, and ensuring that all activities meet the highest standards of safety, efficacy, and quality. The successful candidate will collaborate closely with cross‑functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to streamline regulatory processes and accelerate product launches.

For more career resources, visit Zambia Jobs Search.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations, variations, and renewals in Zambia.
• Prepare, review, and submit comprehensive regulatory dossiers, including CTDs, INDs, and marketing authorisation applications.
• Maintain up‑to‑date knowledge of Zambian pharmaceutical regulations, ICH guidelines, and global best practices.
• Act as the primary liaison with ZAMRA, ensuring timely communication and resolution of regulatory queries.
• Provide regulatory guidance to R&D, Manufacturing, and Marketing teams throughout product lifecycle.
• Lead internal audits and inspections to verify compliance with GMP, GCP, and other relevant standards.
• Monitor and assess regulatory changes, advising senior management on potential impacts.
• Develop and maintain a regulatory intelligence database for the region.
• Support pharmacovigilance activities by ensuring proper reporting of adverse events.
• Mentor junior regulatory staff and foster a culture of continuous improvement.

Required Skills

• In‑depth understanding of Zambian pharmaceutical law and international regulatory frameworks (e.g., FDA, EMA, WHO).
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Strong project management capabilities, including timeline development and stakeholder coordination.
• Analytical mindset with meticulous attention to detail.
• Proficiency in regulatory software tools and Microsoft Office Suite.
• Ability to work independently and as part of a multidisciplinary team.
• Negotiation and problem‑solving skills for interacting with authorities and internal partners.

Education

A Bachelor’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, or a related discipline is required. A Master’s degree or professional certification (e.g., RAC, RAPS) is highly desirable and demonstrates a commitment to regulatory excellence.

Experience

Minimum of eight (8) years of progressive experience in regulatory affairs within the pharmaceutical industry, with at least three (3) years in a managerial or lead role. Experience with product registration in African markets, especially Zambia, is a strong advantage.

Salary

The position offers a competitive salary range of SSP 150,000 to 250,000 per month, commensurate with experience and qualifications. Additional performance‑based incentives may be provided.

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 allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• On‑boarding program covering GSK’s compliance framework and corporate culture.
• Continuous regulatory updates through internal workshops and external seminars.
• Leadership development courses for managerial growth.
• Access to e‑learning platforms for skill enhancement.

Working Environment

GSK Zambia provides a modern, collaborative workspace in Lusaka’s central business district, equipped with state‑of‑the‑art technology and resources. The company promotes a culture of safety, diversity, and inclusion, encouraging employees to share ideas and drive innovation. Flexible working arrangements are available to support work‑life balance, and the organization values employee well‑being through various wellness programs.

Application Process

Interested candidates should submit an online application through GSK’s career portal, attaching a detailed CV and a cover letter outlining relevant experience. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment.

Explore regional opportunities at Ghana Job Search.

Discover additional openings on Malawi Job Search.

Equal Opportunity Statement

GlaxoSmithKline Zambia 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. All qualified applicants will receive consideration for employment without discrimination.