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

Job Description

Position:Regulatory Affairs Manager

Company:GlaxoSmithKline Zambia

Location:Petauke, Zambia

Experience:5+ years in regulatory affairs within pharmaceutical industry

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

Employment Type:Full-time

Industry:Pharmaceutical Manufacturing

Department:Regulatory Affairs

Salary:SSP 180,000 – 250,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline (GSK) Zambia is a leading global healthcare company dedicated to improving the health and well‑being of people worldwide. With a strong presence in Zambia for over two decades, GSK operates state‑of‑the‑art manufacturing facilities, research collaborations, and community health programs. The company’s commitment to innovation, quality, and ethical standards makes it a top employer for professionals seeking meaningful careers in the pharmaceutical sector. As part of GSK’s global network, employees in Zambia benefit from international best practices, continuous learning opportunities, and a culture that values diversity, inclusion, and sustainable impact. GSK Zambia actively supports Zambia Jobs initiatives and contributes to the nation’s economic growth through local sourcing, skill development, and corporate social responsibility.

Job Overview

The Regulatory Affairs Manager will lead GSK Zambia’s regulatory strategy, ensuring that all pharmaceutical products comply with local and international regulations. This role is pivotal in navigating the complex regulatory landscape, preparing submissions, and liaising with the Zambia Medicines Regulatory Authority (ZAMRA). The manager will work closely with cross‑functional teams, including Quality Assurance, Research & Development, and Marketing, to align product development with regulatory requirements. By safeguarding product integrity and market access, the manager directly contributes to GSK’s mission of delivering safe, effective medicines to patients across Zambia. For more information about GSK’s commitment to career growth, visit Zambia Jobs Search.

Key Responsibilities

• Develop and implement regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit dossiers to ZAMRA and other relevant authorities, ensuring accuracy and timeliness.
• Maintain up‑to‑date knowledge of local, regional, and international regulatory guidelines, including WHO, ICH, and EU standards.
• Collaborate with Quality Assurance to ensure that manufacturing processes meet regulatory expectations.
• Provide regulatory guidance to R&D, Marketing, and Supply Chain teams throughout product development.
• Monitor post‑approval compliance, manage variations, and handle product recalls if necessary.
• Represent GSK in regulatory meetings, audits, and inspections, acting as the primary point of contact.
• Train internal staff on regulatory requirements and best practices.
• Prepare regulatory risk assessments and mitigation plans.
• Support the preparation of promotional material reviews to ensure compliance with advertising regulations.

Required Skills

• In‑depth understanding of Zambia’s pharmaceutical regulatory framework and international guidelines.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Strong analytical and problem‑solving abilities.
• Proficiency in regulatory submission software and document management systems.
• Leadership and project management skills to drive cross‑functional initiatives.
• Attention to detail and high level of accuracy.
• Ability to work under pressure and meet strict deadlines.

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 will be considered an advantage.

Experience

Minimum of five (5) years of progressive experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local and international submissions. Experience in a manufacturing environment and familiarity with Good Manufacturing Practices (GMP) are essential.

Salary

The position offers a competitive salary range of SSP 180,000 to 250,000 per month, commensurate with experience and qualifications. Performance‑based incentives and annual bonuses are part of the total compensation package.

Benefits

• Comprehensive health insurance for employee and dependents.
• Retirement savings plan with employer contributions.
• Paid annual leave, sick leave, and public holidays.
• Employee assistance program and wellness initiatives.
• Transportation allowance or company‑provided vehicle for official duties.

Training

• Continuous professional development through GSK’s global learning platforms.
• Access to industry conferences, workshops, and certification courses.
• On‑the‑job mentorship and leadership development programs.

Working Environment

GSK Zambia offers a collaborative, inclusive, and safety‑focused workplace. Employees work in modern office facilities located in Petauke, with easy access to manufacturing sites. The company promotes a healthy work‑life balance and encourages community involvement through volunteer programs.

Application Process

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

Equal Opportunity Statement

GlaxoSmithKline Zambia 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.