Regulatory Affairs Specialist Job Vacancy in Kisumu, Kenya – Pharmaceuticals

Job Description

Position:Regulatory Affairs Specialist

Company:GlaxoSmithKline Kenya

Location:Kisumu, Kenya

Experience:3-5 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 150,000 – 250,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline Kenya (GSK Kenya) is a leading global healthcare company dedicated to improving the health and well-being of people worldwide. With a strong presence in Kenya for over three decades, GSK Kenya operates state‑of‑the‑art manufacturing facilities, research hubs, and a robust commercial network that reaches every corner of the country. The company’s mission aligns with the United Nations Sustainable Development Goals, focusing on innovative medicines, vaccines, and consumer health products that address critical health challenges in Kenya and across Africa. As part of GSK’s global commitment to excellence, the Kisumu office serves as a strategic hub for regulatory affairs, ensuring that all products meet the highest standards of safety, efficacy, and compliance.

Joining GSK Kenya means becoming part of a diverse, inclusive, and forward‑thinking workforce that values scientific rigor, ethical conduct, and continuous learning. The organization consistently ranks among the top employers in Kenya, offering career pathways that empower employees to make a tangible impact on public health. This role contributes directly to GSK’s vision of helping people do more, feel better, and live longer, making it an exciting opportunity for professionals seeking meaningful work in the pharmaceutical sector.

Job Overview

The Regulatory Affairs Specialist will be responsible for managing the end‑to‑end regulatory lifecycle of GSK’s pharmaceutical products in Kenya. This includes preparing and submitting dossiers to the Pharmacy and Poisons Board, maintaining product registrations, and ensuring ongoing compliance with local and international regulations. The specialist will act as the primary liaison between GSK’s internal teams, external regulatory authorities, and key stakeholders, providing strategic guidance on regulatory strategies that support product launches and market expansion. This position plays a pivotal role in safeguarding public health while enabling GSK to bring innovative therapies to patients across Kenya.

As part of the broader Regulatory Affairs department, the specialist will collaborate closely with Quality Assurance, Clinical Development, Marketing, and Legal teams to align regulatory requirements with business objectives. The role demands a proactive mindset, strong analytical skills, and the ability to navigate complex regulatory environments. By joining GSK Kenya, you will be at the forefront of shaping the regulatory landscape for life‑saving medicines, contributing to the company’s reputation for excellence and integrity.

For more information about GSK Kenya’s mission and values, visit our main website https://kenyajobsearch.com. Additional resources on career development in the pharmaceutical industry can be found at https://www.angolajobsearch.com/.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new product registrations, variations, and renewals to the Pharmacy and Poisons Board.
• Maintain and update product registration files, ensuring all documentation is current and compliant.
• Monitor changes in Kenyan pharmaceutical regulations and advise internal teams on impact and required actions.
• Collaborate with cross‑functional teams to develop regulatory strategies that support product launch timelines and market access.
• Serve as the primary point of contact for regulatory authorities, responding to queries, inspections, and audits.
• Conduct risk assessments and develop mitigation plans for regulatory compliance issues.
• Provide regulatory training and guidance to internal stakeholders on best practices and compliance requirements.
• Support post‑marketing surveillance activities, including adverse event reporting and product safety updates.

Required Skills

• In‑depth knowledge of Kenyan pharmaceutical regulations and international guidelines (e.g., ICH, WHO).
• Strong written and verbal communication skills, with the ability to present complex information clearly.
• Excellent organizational and project management abilities, capable of handling multiple dossiers simultaneously.
• Proficiency in regulatory software tools and Microsoft Office Suite.
• Analytical mindset with strong problem‑solving capabilities.
• Ability to work collaboratively in a multidisciplinary environment.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. A Master’s degree or professional certification in Regulatory Affairs (e.g., RAC) is highly desirable and will be considered an advantage during the selection process.

Experience

Applicants must have a minimum of 3 to 5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to product registration processes in Kenya. Experience working with the Pharmacy and Poisons Board and familiarity with global regulatory submissions are essential.

Salary

The position offers a competitive salary range of SSP 150,000 to 250,000 per month, commensurate with experience and qualifications. GSK Kenya also provides performance‑based bonuses, comprehensive health benefits, and a pension scheme.

Benefits

• Medical and dental coverage for employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid time off and parental leave.
• Employee assistance program and wellness initiatives.
• Professional development allowance and tuition reimbursement.

Training

• On‑boarding program covering GSK’s regulatory processes and corporate culture.
• Continuous learning opportunities through internal GSK Academy and external certifications.
• Mentorship from senior regulatory leaders and access to global regulatory networks.

Working Environment

GSK Kenya offers a modern, collaborative workspace in Kisumu equipped with the latest technology and resources. The company promotes a culture of safety, inclusivity, and innovation, encouraging employees to share ideas and drive positive change. Flexible working arrangements and a supportive team environment ensure a healthy work‑life balance.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the GSK Careers portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview. Please ensure all documents are in PDF format.

Equal Opportunity Statement

GlaxoSmithKline Kenya 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. Join us and be part of a team that values your unique perspective and contributions.