Regulatory Affairs Specialist Job Vacancy in Kapoeta, South Sudan – Pharmaceuticals

Job Description

Position:Regulatory Affairs Specialist

Company:Johnson & Johnson

Location:Kapoeta, South Sudan

Experience:3-5 years

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

Employment Type:Full-time

Industry:Pharmaceuticals

Department:Regulatory Affairs

Salary:30,000,000 – 45,000,000 SSP per annum

Vacancies:1

Company Overview

Johnson & Johnson is a globally recognized leader in health care, dedicated to improving the well‑being of people worldwide. With a strong commitment to innovation, quality, and ethical standards, the company operates across pharmaceuticals, medical devices, and consumer health products. In South Sudan, Johnson & Johnson has partnered with local health ministries and NGOs to enhance access to essential medicines and support capacity building in the pharmaceutical sector. This presence creates a dynamic environment for professionals seeking to contribute to impactful health solutions while advancing their careers. As part of its strategic expansion, the company is establishing a regulatory hub in Kapoeta, a key location for reaching underserved communities in the eastern region of South Sudan. This hub will play a pivotal role in ensuring that all products meet local and international regulatory requirements, reinforcing the company’s reputation for safety and compliance.

Job Overview

The Regulatory Affairs Specialist will be responsible for managing the submission, review, and maintenance of product registrations with the South Sudanese National Medicines Regulatory Authority (NMRA). This role involves close collaboration with cross‑functional teams, including research & development, quality assurance, and marketing, to ensure that all pharmaceutical products comply with local laws and global standards. The specialist will also monitor regulatory changes, provide strategic guidance, and act as the primary liaison between Johnson & Johnson and regulatory bodies. This position offers a unique opportunity to influence public health outcomes while gaining exposure to international regulatory frameworks. For more information about our commitment to the region, visit our career portal.

Key Responsibilities

• Prepare, compile, and submit dossiers for product registration, renewal, and variation to the NMRA.
• Maintain an up‑to‑date regulatory intelligence database covering South Sudanese and regional legislative updates.
• Coordinate with R&D, Quality, and Marketing teams to ensure alignment of product labeling, packaging, and promotional materials with regulatory requirements.
• Provide regulatory guidance throughout the product lifecycle, from clinical trials to post‑marketing surveillance.
• Facilitate inspections and audits by regulatory authorities, ensuring readiness and compliance.
• Develop and deliver internal training on regulatory policies and best practices.
• Support the preparation of risk assessments and pharmacovigilance reports as required by local regulations.

Required Skills

• In‑depth knowledge of South Sudanese pharmaceutical regulations and international guidelines (e.g., WHO, ICH).
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills in English; proficiency in Arabic or local languages is a plus.
• Ability to manage multiple projects simultaneously and meet tight deadlines.
• Proficiency with regulatory submission software and Microsoft Office Suite.
• Collaborative mindset with experience working in cross‑functional teams.

Education

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

Experience

Candidates must have a minimum of three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to emerging markets. Experience with product registration in African regulatory environments is strongly preferred.

Salary

The compensation package ranges from 30,000,000 to 45,000,000 South Sudanese Pounds (SSP) per annum, commensurate with experience and qualifications. The package includes performance‑based incentives and benefits outlined below.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Paid annual leave and sick leave in accordance with South Sudan labor law.
• Transportation allowance for commuting to the Kapoeta office.
• Employee assistance program and wellness initiatives.

Training

• On‑the‑job regulatory training and mentorship from senior compliance experts.
• Access to global e‑learning platforms for continuous professional development.
• Opportunities to attend international regulatory conferences and workshops.

Working Environment

The role is based in a modern office facility in Kapoeta, equipped with reliable internet connectivity and collaborative workspaces. Employees benefit from a supportive culture that values diversity, innovation, and ethical conduct. The office promotes a balance between focused individual work and team‑oriented projects, fostering a dynamic atmosphere for professional growth.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online application portal on our website. 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 Kapoeta.

Equal Opportunity Statement

Johnson & Johnson is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of race, gender, age, disability, religion, or sexual orientation. Our hiring practices reflect our dedication to fairness and respect, ensuring that every applicant receives equal consideration for employment.