Regulatory Affairs Manager Job Vacancy in Nairobi, Kenya – Pharmaceuticals

Job Description

Position: Regulatory Affairs Manager

Company: Pfizer Kenya

Location: Nairobi, Kenya

Experience: 5+ years in regulatory affairs within pharmaceutical industry

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 250,000 – SSP 400,000 per month

Vacancies:1

Company Overview

Pfizer Kenya is a leading global pharmaceutical company dedicated to improving health outcomes across Africa. With a strong presence in Nairobi, Pfizer Kenya combines cutting‑edge research, robust manufacturing capabilities, and a commitment to ethical business practices. As part of a worldwide network, the company brings innovative medicines, vaccines, and health solutions to patients, healthcare professionals, and governments. The organization values diversity, inclusion, and continuous learning, fostering a culture where employees can thrive while contributing to the advancement of healthcare in Kenya and beyond. This role offers a unique opportunity to be part of a dynamic team that drives regulatory excellence, ensuring that life‑saving products meet the highest standards of safety and efficacy. Join Pfizer Kenya and be part of a mission that aligns with the growing demand for quality healthcare in Kenya, supporting the broader goal of enhancing public health across the continent.

For more information about Pfizer Kenya’s global impact, visit the Kenya Job Search portal.

Job Overview

The Regulatory Affairs Manager will lead the strategic planning, preparation, and submission of regulatory dossiers for new and existing pharmaceutical products in Kenya. This role ensures compliance with the Pharmacy and Poisons Board (PPB) regulations, as well as international guidelines such as ICH and WHO. The manager will collaborate closely with cross‑functional teams, including Clinical Development, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. By maintaining strong relationships with regulatory authorities and staying abreast of evolving legislation, the manager will safeguard product approvals and market access, directly contributing to Pfizer Kenya’s growth and reputation for excellence.

Explore additional career resources at the South Sudan Job Search site.

Key Responsibilities

• Develop and execute regulatory strategies for product registrations, variations, and renewals in Kenya.
• Prepare, review, and submit comprehensive dossiers, including INDs, NDAs, ANDAs, and post‑approval variations.
• Maintain ongoing communication with the Pharmacy and Poisons Board, ensuring timely responses to queries and inspections.
• Interpret and implement local and international regulatory requirements, providing guidance to internal teams.
• Lead cross‑functional meetings to align regulatory activities with clinical, manufacturing, and commercial timelines.
• Monitor changes in Kenyan pharmaceutical legislation and advise senior management on impact and mitigation.
• Oversee the preparation of labeling, packaging, and promotional material to ensure compliance.
• Mentor junior regulatory staff, fostering professional development and knowledge sharing.

Required Skills

• In‑depth knowledge of Kenyan pharmaceutical regulations and ICH guidelines.
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills for effective stakeholder engagement.
• Proven project management experience, handling multiple dossiers simultaneously.
• Ability to work collaboratively across multidisciplinary teams.
• Proficiency in regulatory submission software and Microsoft Office Suite.

Education

A minimum of 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

Candidates must have at least five years of progressive experience in regulatory affairs within the pharmaceutical industry, preferably with a track record of successful product registrations in Kenya or other African markets.

Salary

The compensation package ranges from SSP 250,000 to SSP 400,000 per month, commensurate with experience, qualifications, and performance. The package includes performance‑based bonuses and comprehensive benefits.

Benefits

• Competitive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid time off and sick leave.
• Professional development allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• Onboarding program covering Pfizer’s regulatory processes and compliance culture.
• Continuous learning opportunities through internal e‑learning platforms.
• Access to global regulatory workshops and webinars.
• Mentorship from senior regulatory leaders across Pfizer’s international network.

Working Environment

Pfizer Kenya offers a modern, collaborative office environment in Nairobi’s central business district, equipped with state‑of‑the‑art technology and flexible work arrangements. The culture promotes innovation, accountability, and a strong sense of purpose, encouraging employees to contribute ideas that drive regulatory excellence and patient safety.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their regulatory experience through the online portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for interviews. For detailed application instructions, visit the Cameroon Job Search page for guidance on preparing a compelling submission.

Equal Opportunity Statement

Pfizer Kenya is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, gender, age, religion, disability, sexual orientation, or any other protected characteristic. All qualified applicants will receive consideration for employment without discrimination.