Regulatory Affairs Specialist Job Vacancy in Nairobi, Kenya – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: GlaxoSmithKline Kenya

Location: Nairobi, Kenya

Experience: 3-5 years in regulatory affairs within the pharmaceutical industry

Education: Bachelor’s degree in Pharmacy, Chemistry, 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 multinational pharmaceutical and healthcare company with a strong commitment to improving the health and well‑being of people across Kenya. Established over three decades ago, GSK Kenya operates state‑of‑the‑art manufacturing facilities, research laboratories, and a robust distribution network that reaches every corner of the country. The company is renowned for its innovative medicines, vaccines, and consumer health products that address critical health challenges in both urban and rural communities.

As part of GSK’s global mission, the Kenyan subsidiary aligns with international standards of quality, safety, and regulatory compliance. The organization fosters a culture of continuous learning, diversity, and inclusion, offering career pathways that empower employees to make a tangible impact on public health. With a focus on sustainable growth, GSK Kenya collaborates with local universities, research institutions, and government agencies to drive scientific advancement and capacity building.

GSK Kenya is actively contributing to Kenya Jobs and is recognized as a top employer for those seeking dynamic career opportunities in the pharmaceutical sector. The company’s commitment to ethical practices, community outreach, and employee development makes it an attractive destination for professionals looking to advance their careers in Kenya.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that all GSK Kenya products meet the regulatory requirements of the Kenya Pharmacy and Poisons Board as well as international standards. This position involves preparing, reviewing, and submitting regulatory dossiers, maintaining product registrations, and providing strategic guidance to cross‑functional teams on compliance matters. The specialist will act as a liaison between GSK Kenya and regulatory authorities, facilitating smooth product approvals and market entry.

As part of the role, you will work closely with the Global Regulatory Affairs team, Quality Assurance, Clinical Development, and Commercial Operations to align local strategies with global regulatory frameworks. This is an excellent opportunity for professionals seeking to deepen their expertise in regulatory affairs while contributing to the health of millions of Kenyans. For more information about GSK Kenya and its commitment to excellence, visit https://kenyajobsearch.com/.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new product registrations, variations, and renewals in compliance with Kenya Pharmacy and Poisons Board guidelines.
• Maintain and update product registration files, ensuring all documentation is current and audit‑ready.
• Provide regulatory intelligence and strategic advice to product development, marketing, and manufacturing teams.
• Coordinate with Global Regulatory Affairs to align local submissions with global strategies and timelines.
• Monitor changes in local and international regulations, assess impact, and implement necessary compliance actions.
• Represent GSK Kenya in meetings with regulatory authorities, responding to queries and facilitating inspections.
• Develop and deliver regulatory training sessions for internal stakeholders.
• Support post‑marketing surveillance activities and ensure timely reporting of adverse events.

Required Skills

• In‑depth knowledge of Kenyan pharmaceutical regulations and ICH guidelines.
• Strong analytical and problem‑solving abilities.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Proficiency in preparing regulatory documents, including CTDs, INDs, and marketing authorisation applications.
• Ability to work collaboratively across multidisciplinary teams.
• High level of attention to detail and organizational skills.
• Proficiency in Microsoft Office Suite and regulatory submission software.

Education

A Bachelor’s degree in Pharmacy, Chemistry, Pharmacology, or a related scientific 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 both local and international submissions. Experience working with the Kenya Pharmacy and Poisons Board or similar regulatory bodies is a strong plus.

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 and benefits are part of the total compensation package.

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.
• Transportation allowance for commuting within Nairobi.

Training

• On‑boarding program covering GSK’s global regulatory policies and local compliance requirements.
• Continuous learning opportunities through GSK’s internal learning platform.
• Mentorship from senior regulatory leaders across the GSK network.
• Access to external regulatory workshops and industry seminars.

Working Environment

GSK Kenya offers a collaborative, inclusive, and innovative workplace located in the vibrant business district of Nairobi. Employees benefit from modern office facilities, flexible working arrangements, and a culture that encourages knowledge sharing and career progression. The organization promotes a healthy work‑life balance and values diversity as a driver of creativity and performance.

Application Process

Interested candidates are invited to submit their updated CV and a cover letter outlining their suitability for the role through the online application portal on the GSK Kenya careers page. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview. Please ensure all documents are uploaded 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, colour, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status. GSK Kenya encourages applications from women, persons with disabilities, and members of under‑represented groups.

Explore this exciting career opportunity and join a team dedicated to improving health outcomes across Kenya. This role is a prime example of the vibrant Kenya Jobs market, offering meaningful work, professional growth, and the chance to make a lasting impact.