Regulatory Affairs Specialist Job Vacancy in Manzini, Eswatini – Pharmaceuticals
Job Description
Position: Regulatory Affairs Specialist
Company: GlaxoSmithKline (GSK)
Location: Manzini, Eswatini
Experience: 3-5 years in regulatory affairs within pharmaceutical industry
Education: Bachelor’s degree in Pharmacy, Life Sciences, or related field
Employment Type: Full-time
Industry: Pharmaceuticals
Department: Regulatory Affairs
Salary: SSP 30,000 – 45,000 per month
Vacancies:1
Company Overview
GlaxoSmithKline (GSK) is a global healthcare leader dedicated to improving the quality of life through innovative medicines, vaccines, and consumer health products. With a strong presence across Africa, GSK operates state‑of‑the‑art manufacturing facilities, research hubs, and commercial offices that adhere to the highest standards of quality and compliance. In Eswatini, GSK has been a trusted partner for the Ministry of Health, supplying essential medicines and supporting public health initiatives. The company’s commitment to ethical practices, sustainability, and community development makes it an attractive employer for professionals seeking meaningful impact. GSK’s culture encourages continuous learning, collaboration, and diversity, ensuring that every employee can thrive while contributing to the global mission of delivering health solutions that matter.
Job Overview
The Regulatory Affairs Specialist will play a pivotal role in ensuring that all GSK products marketed in Eswatini meet local and international regulatory requirements. This position involves preparing and submitting dossiers, liaising with the Eswatini Medicines Regulatory Authority, and providing strategic guidance to cross‑functional teams on compliance matters. The specialist will also monitor regulatory changes, assess their impact on product pipelines, and support the development of risk mitigation strategies. This role offers a unique opportunity to work at the intersection of science, law, and business, contributing directly to the safe and timely delivery of life‑saving medicines to patients across the nation.
Key Responsibilities
- Prepare, review, and submit regulatory dossiers for new product registrations, variations, and renewals in compliance with Eswatini regulations.
- Maintain up‑to‑date knowledge of local regulatory guidelines, international standards (e.g., ICH, WHO), and industry best practices.
- Act as the primary liaison between GSK and the Eswatini Medicines Regulatory Authority, facilitating clear communication and timely resolution of queries.
- Collaborate with R&D, Quality Assurance, Manufacturing, and Marketing teams to ensure regulatory considerations are integrated throughout product development.
- Develop and implement regulatory strategies that align with business objectives and market access goals.
- Monitor and assess the impact of regulatory changes on existing and pipeline products, providing actionable recommendations.
- Prepare regulatory intelligence reports and maintain a comprehensive database of regulatory submissions and approvals.
- Support internal audits and inspections by providing necessary documentation and evidence of compliance.
Required Skills
- Strong understanding of pharmaceutical regulatory frameworks and submission processes.
- Excellent written and verbal communication skills, with the ability to convey complex regulatory information clearly.
- Analytical mindset with strong problem‑solving abilities and attention to detail.
- Proficiency in regulatory software tools and Microsoft Office Suite.
- Ability to work independently and as part of multidisciplinary teams.
- Project management skills, including the ability to prioritize tasks and meet strict deadlines.
- Fluency in English; knowledge of SiSwati is an advantage.
Education
A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Candidates with additional certifications in regulatory affairs (e.g., RAC, RAPS) or a Master’s degree will be given preference.
Experience
Applicants should have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local and international submission processes. Experience working with the Eswatini Medicines Regulatory Authority or similar African regulatory bodies is highly desirable.
Salary
The position offers a competitive salary range of SSP 30,000 to 45,000 per month, commensurate with experience and qualifications. GSK also provides performance‑based bonuses, health insurance, and a comprehensive retirement plan.
Benefits
- Comprehensive medical, dental, and vision coverage.
- Retirement savings scheme with employer contributions.
- Paid parental and annual leave.
- Employee assistance program and wellness initiatives.
- Access to GSK’s global learning platforms and career development resources.
Training
- On‑boarding program covering GSK’s compliance culture, systems, and processes.
- Continuous professional development courses in regulatory science, project management, and leadership.
- Opportunities to attend regional regulatory conferences and workshops.
Working Environment
GSK’s Manzini office provides a modern, collaborative workspace equipped with the latest technology to support remote and hybrid working arrangements. The company fosters an inclusive culture where diverse perspectives are valued, and employees are encouraged to share ideas that drive innovation. Safety, integrity, and respect are core pillars of the workplace, ensuring a supportive environment for all staff.
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 invited for a virtual interview followed by an on‑site assessment. For further information on the application steps, please visit the following link:
https://ethiopiajobssearch.com/
Additional details about GSK’s commitment to diversity and employee growth can be found here:
Equal Opportunity Statement
GlaxoSmithKline 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.
