Regulatory Affairs Specialist Job Vacancy in Mbarara, Uganda – Pharmaceuticals & Healthcare

Job Description

Position:Regulatory Affairs Specialist

Company:GlaxoSmithKline Uganda

Location:Mbarara, Uganda

Experience:3-5 years

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

Employment Type:Full-time

Industry:Pharmaceuticals & Healthcare

Department:Regulatory Affairs

Salary:SSP 2,500,000 – SSP 3,500,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline Uganda (GSK Uganda) is a leading global healthcare company dedicated to improving the quality of life through innovative medicines, vaccines, and consumer health products. With a strong presence across East Africa, GSK Uganda operates state‑of‑the‑art manufacturing facilities, research laboratories, and a robust distribution network that reaches both urban and rural communities. The company’s commitment to ethical standards, sustainability, and community engagement makes it a preferred employer for professionals seeking meaningful impact in the pharmaceutical sector. As part of GSK’s global mission, the Uganda branch actively collaborates with local health authorities, academic institutions, and non‑governmental organizations to advance public health outcomes and support the nation’s healthcare infrastructure.

GSK Uganda’s culture fosters continuous learning, diversity, and inclusion, encouraging employees to bring their unique perspectives to solve complex health challenges. The organization invests heavily in employee development, offering mentorship programs, leadership training, and opportunities for international exposure. By joining GSK Uganda, you become part of a dynamic team that values scientific excellence, regulatory compliance, and a patient‑centric approach.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that all GSK Uganda products meet local and international regulatory requirements. This position involves preparing and submitting dossiers, liaising with the National Drug Authority (NDA), and staying abreast of evolving regulatory guidelines. The specialist will collaborate closely with cross‑functional teams, including Research & Development, Quality Assurance, and Marketing, to guarantee seamless product registration and lifecycle management. This role is essential for maintaining GSK’s reputation for compliance, safety, and efficacy in the Ugandan market.

As part of your daily responsibilities, you will interpret regulatory policies, provide strategic advice on product labeling, and support post‑marketing surveillance activities. The position offers a unique opportunity to influence the introduction of life‑saving medicines and vaccines to Ugandan patients while advancing your career within a globally recognized pharmaceutical leader.

For more information about GSK Uganda’s mission and career opportunities, visit our main website: https://ugandajobssearch.com

Explore regional job trends and insights at https://algeriajobsearch.com/job-vacancy-algeria/

Learn about comparable roles across Southern Africa at https://southafricajobsearch.com/job-vacancy-in-south-africa/

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new product registrations, variations, and renewals in compliance with NDA guidelines.
• Maintain an up‑to‑date regulatory intelligence database, monitoring changes in Ugandan and international regulations that affect product lifecycle.
• Collaborate with R&D, Quality Assurance, and Marketing teams to ensure alignment of product specifications, labeling, and promotional materials with regulatory standards.
• Provide regulatory strategy input during product development, clinical trial design, and post‑approval activities.
• Serve as the primary point of contact with the National Drug Authority, facilitating inspections, audits, and addressing queries promptly.
• Develop and deliver internal training sessions on regulatory requirements and best practices.
• Support pharmacovigilance activities by reviewing adverse event reports and ensuring timely submission to regulatory bodies.
• Prepare and maintain comprehensive regulatory documentation, including standard operating procedures (SOPs) and compliance reports.

Required Skills

• In‑depth knowledge of Ugandan pharmaceutical regulations and International Council for Harmonisation (ICH) guidelines.
• Excellent written and verbal communication skills, with the ability to draft clear regulatory submissions.
• Strong analytical and problem‑solving abilities, capable of interpreting complex regulatory texts.
• Proficiency in regulatory software tools and Microsoft Office Suite.
• Ability to work collaboratively in cross‑functional teams and manage multiple projects simultaneously.
• Attention to detail and a commitment to maintaining high standards of compliance.

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.

Experience

Minimum of 3 to 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, preferably with direct exposure to the Ugandan regulatory environment.

Salary

The successful candidate will receive a competitive monthly salary ranging from SSP 2,500,000 to SSP 3,500,000, commensurate with experience and qualifications. Additional performance‑based incentives and benefits are offered.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid leave, including annual, sick, and parental leave.
• Employee assistance program and wellness initiatives.
• Opportunities for international assignments and conferences.

Training

• On‑boarding program covering GSK’s compliance framework and corporate culture.
• Continuous professional development courses in regulatory science, pharmacovigilance, and leadership.
• Access to GSK’s global learning platform for certifications and skill enhancement.

Working Environment

GSK Uganda offers a modern, collaborative workspace located in the heart of Mbarara’s industrial park. The environment promotes teamwork, innovation, and a healthy work‑life balance. Employees benefit from flexible working arrangements, a supportive management team, and a culture that celebrates diversity and inclusion.

Application Process

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

Equal Opportunity Statement

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