Regulatory Affairs Manager Job Vacancy in Maseru, Lesotho – Pharmaceuticals & Healthcare

Job Description

Position: Regulatory Affairs Manager

Company: Johnson & Johnson

Location: Maseru, Lesotho

Experience: 5+ years in pharmaceutical regulatory affairs

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

Employment Type: Full-time

Industry: Pharmaceuticals & Healthcare

Department: Regulatory Affairs

Salary: SSP 350,000 – SSP 500,000 per annum

Vacancies:1

Company Overview

Johnson & Johnson is a globally recognized leader in health care, dedicated to improving the lives of people worldwide through innovative medicines, medical devices, and consumer health products. With a strong commitment to emerging markets, Johnson & Johnson has established a regional hub in Maseru, Lesotho, to support local manufacturing, distribution, and regulatory compliance. The company’s presence in Lesotho aligns with national goals for health system strengthening and offers a dynamic environment for professionals seeking meaningful impact. As part of our global network, employees in Lesotho benefit from world‑class resources, cross‑border collaboration, and a culture that values diversity, integrity, and scientific excellence. This role contributes directly to Johnson & Johnson’s mission of advancing health and wellness across the continent, making it an exciting opportunity for ambitious regulatory professionals.

Our Lesotho operations are strategically positioned to serve Southern Africa, ensuring that essential medicines reach patients efficiently while adhering to the highest standards of safety and efficacy. By joining our team, you become part of a forward‑thinking organization that invests heavily in research, development, and community outreach, creating a sustainable ecosystem for health innovation. The Regulatory Affairs Manager will play a pivotal role in navigating the complex regulatory landscape of Lesotho and neighboring countries, supporting product registrations, and ensuring compliance with both local and international guidelines. This position offers a unique blend of strategic influence, technical expertise, and leadership development, making it a cornerstone of our regulatory function.

Job Overview

The Regulatory Affairs Manager will lead all regulatory activities for Johnson & Johnson’s pharmaceutical portfolio in Lesotho, overseeing product submissions, label approvals, and post‑marketing surveillance. Reporting to the Regional Regulatory Director, you will collaborate closely with cross‑functional teams including Clinical, Quality Assurance, Manufacturing, and Marketing to ensure that all products meet the stringent requirements of the Lesotho Ministry of Health and other relevant authorities. This role demands a deep understanding of local regulatory frameworks, strong project management skills, and the ability to influence stakeholders at all levels. You will be responsible for developing regulatory strategies that accelerate market access while maintaining compliance, thereby supporting the company’s growth objectives and reinforcing its reputation for excellence in the healthcare sector.

For more information about our global career portal, visit Lesotho Job Search.

Explore regional opportunities at Mozambique Job Search.

Key Responsibilities

• Prepare, submit, and manage dossiers for product registration, variations, and renewals with the Lesotho Medicines Regulatory Authority.
• Develop and implement regulatory strategies that align with business goals and market timelines.
• Coordinate with Clinical, Quality, and Manufacturing teams to ensure data integrity and compliance throughout the product lifecycle.
• Maintain up‑to‑date knowledge of local and international regulations, guidelines, and industry best practices.
• Lead interactions with regulatory authorities, addressing queries, inspections, and audits.
• Provide regulatory guidance on labeling, packaging, advertising, and promotional materials.
• Monitor post‑marketing safety data and ensure timely reporting of adverse events.
• Train internal stakeholders on regulatory requirements and changes.
• Prepare regulatory intelligence reports and contribute to continuous improvement initiatives.

Required Skills

• Strong knowledge of Lesotho pharmaceutical regulations and ICH guidelines.
• Excellent written and verbal communication skills, with the ability to convey complex regulatory concepts clearly.
• Proven project management capabilities, including timeline development and risk mitigation.
• Analytical mindset with attention to detail and problem‑solving aptitude.
• Ability to work collaboratively across multidisciplinary teams and influence decision‑making.
• Proficiency in regulatory submission software and Microsoft Office suite.
• Fluency in English; knowledge of Sesotho is an advantage.

Education

A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related 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

Minimum of five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African regulatory environments. Experience managing end‑to‑end product registrations and leading cross‑functional projects is essential.

Salary

The compensation package ranges from SSP 350,000 to SSP 500,000 annually, commensurate with experience and qualifications. The package includes performance‑based incentives, health benefits, and retirement contributions.

Benefits

• Comprehensive medical, dental, and vision coverage.
• Retirement savings plan with employer matching.
• Generous paid time off and parental leave.
• Professional development allowance and tuition reimbursement.
• Employee assistance program and wellness initiatives.

Training

• On‑boarding program covering Johnson & Johnson’s regulatory processes and corporate culture.
• Access to global regulatory training platforms and certification courses.
• Mentorship from senior regulatory leaders across the region.
• Regular workshops on emerging regulatory trends and compliance tools.

Working Environment

Our Maseru office offers a collaborative, inclusive, and modern workspace equipped with state‑of‑the‑art technology. Employees enjoy a supportive culture that encourages innovation, continuous learning, and work‑life balance. As part of a global organization, you will have opportunities to engage with colleagues worldwide, participate in cross‑regional projects, and contribute to initiatives that have a tangible impact on public health.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining relevant experience through the Johnson & Johnson careers portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment in Maseru.

Equal Opportunity Statement

Johnson & Johnson 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.