Regulatory Affairs Manager Job Vacancy in Maltahöhe, Namibia – Pharmaceuticals

Job Description

Position:Regulatory Affairs Manager

Company:Pfizer Namibia

Location:Maltahöhe, Namibia

Experience: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 350,000 – SSP 500,000 per annum

Vacancies:1

Company Overview

Pfizer is a globally recognized leader in innovative medicines, vaccines, and consumer health products. With a strong commitment to improving health outcomes worldwide, Pfizer operates in over 150 countries, including a dedicated regional hub in Namibia. The Namibia office supports the distribution of essential medicines, collaborates with local health authorities, and invests in community health initiatives. As part of Pfizer’s mission to bring breakthroughs that change patients’ lives, the Maltahöhe site plays a strategic role in ensuring regulatory compliance across the Southern African region. This is an exciting opportunity for professionals seeking to contribute to a world‑class pharmaceutical organization while advancing their career in a dynamic, purpose‑driven environment. Namibia Jobs, Jobs in Namibia, and Career Opportunities in Namibia are at the heart of Pfizer’s local talent strategy.

Job Overview

The Regulatory Affairs Manager will lead the development, submission, and maintenance of regulatory dossiers for Pfizer’s product portfolio in Namibia and neighboring markets. Reporting to the Head of Regulatory Affairs, you will act as the primary liaison between Pfizer, the Namibia Medicines Regulatory Authority (NAMRA), and other governmental bodies. Your expertise will ensure that all products meet local and international standards, facilitating timely market access and safeguarding public health. This role offers a unique blend of strategic planning, cross‑functional collaboration, and hands‑on regulatory execution. For more information about Pfizer’s global impact, visit https://namibiajobsearch.com. Additional resources on regulatory careers in Southern Africa can be found at https://www.eswatinijobsearch.com/. The position supports Namibia’s growing pharmaceutical sector and contributes to the broader goal of enhancing healthcare delivery across the region.

Key Responsibilities

• Develop and execute regulatory strategies for new product registrations, variations, and renewals.
• Prepare, review, and submit comprehensive dossiers to NAMRA and other relevant authorities.
• Maintain up‑to‑date knowledge of local and international regulations, guidelines, and industry best practices.
• Coordinate with cross‑functional teams including Clinical, Quality, Manufacturing, and Marketing to gather necessary documentation.
• Lead internal audits and inspections to ensure compliance with Good Manufacturing Practice (GMP) and Good Clinical Practice (GCP) standards.
• Provide regulatory guidance and training to internal stakeholders.
• Monitor post‑approval commitments and manage product lifecycle activities.
• Represent Pfizer in regulatory meetings, workshops, and industry forums.

Required Skills

• In‑depth understanding of Namibia’s Medicines Act and related regulatory frameworks.
• Strong analytical and problem‑solving abilities.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Proficiency in regulatory submission software and document management systems.
• Project management expertise, including timeline and resource coordination.
• Ability to work collaboratively in a multicultural, cross‑functional environment.

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 demonstrates a commitment to regulatory excellence.

Experience

Minimum of five years’ experience in regulatory affairs within the pharmaceutical industry, preferably with direct experience submitting dossiers to African regulatory agencies. Prior experience in a multinational company is advantageous.

Salary

The role offers a competitive salary range of SSP 350,000 to SSP 500,000 per annum, commensurate with experience and qualifications. Performance‑based incentives and annual bonuses are also part of the compensation package.

Benefits

• Comprehensive health insurance covering medical, dental, and vision.
• Retirement savings plan with employer contributions.
• Generous paid time off and parental leave.
• Employee assistance program and wellness initiatives.
• Relocation assistance for candidates moving to Maltahöhe.

Training

• Continuous professional development through Pfizer’s global learning platform.
• Access to industry conferences, workshops, and certification courses.
• On‑the‑job mentorship from senior regulatory leaders.

Working Environment

Pfizer provides a modern, collaborative workspace equipped with the latest technology to support regulatory activities. The Maltahöhe office fosters a culture of innovation, inclusion, and respect, encouraging employees to share ideas and drive positive change. Flexible working arrangements are available to promote work‑life balance.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on the Pfizer Careers website. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview.

Equal Opportunity Statement

Pfizer 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, sex, sexual orientation, gender identity, national origin, disability, or veteran status.