Job Description
Position: Regulatory Affairs Manager
Company: Pfizer Inc.
Location: Nimule, South Sudan
Experience: 5-7 years in regulatory affairs within pharmaceuticals
Education: Bachelor’s degree in Pharmacy, Life Sciences, or related field
Employment Type: Full-time
Industry: Pharmaceuticals
Department: Regulatory Affairs
Salary: SSP 30,000,000 – SSP 45,000,000 per month
Vacancies:1
Company Overview
Pfizer Inc. is a global leader in innovative medicines, vaccines, and consumer health products, dedicated to improving health outcomes worldwide. With a strong commitment to research and development, Pfizer operates in over 150 countries, delivering life‑saving therapies to patients in diverse markets. In South Sudan, Pfizer collaborates with local health ministries, NGOs, and private sector partners to ensure the availability of essential medicines and to support capacity building in the pharmaceutical sector. This presence creates a dynamic environment for professionals seeking to make a meaningful impact on public health while advancing their careers in a multinational setting. The role contributes directly to Pfizer’s mission of delivering breakthroughs that change patients’ lives, aligning with the growing demand for high‑quality pharmaceutical products in South Sudan.
Job Overview
The Regulatory Affairs Manager will lead the preparation, submission, and maintenance of regulatory dossiers for Pfizer’s products entering the South Sudan market. This position ensures compliance with national and international regulations, liaises with the South Sudan Ministry of Health, and coordinates with cross‑functional teams to streamline product approvals. The role is pivotal in navigating the regulatory landscape, supporting product launches, and maintaining ongoing compliance throughout the product lifecycle. For more information about our commitment to South Sudan Jobs, visit South Sudan Job Search.
Key Responsibilities
- Develop and execute regulatory strategies for new product registrations and variations.
- Prepare and submit comprehensive dossiers to the South Sudan Ministry of Health and other relevant authorities.
- Maintain up‑to‑date knowledge of local pharmaceutical regulations, guidelines, and policy changes.
- Coordinate with internal teams including Clinical, Quality, and Marketing to gather required documentation.
- Act as the primary point of contact for regulatory agencies, ensuring timely communication and issue resolution.
- Monitor post‑approval compliance, manage renewals, and handle product labeling updates.
- Provide regulatory guidance and training to project teams and local partners.
- Support risk assessments and ensure that all activities align with Pfizer’s global standards.
Required Skills
- In‑depth understanding of South Sudan’s pharmaceutical regulatory framework.
- Strong analytical and problem‑solving abilities.
- Excellent written and verbal communication skills in English; knowledge of Arabic is an advantage.
- Proven ability to manage multiple projects and meet strict deadlines.
- Detail‑oriented with a focus on accuracy and compliance.
- Effective stakeholder management and negotiation skills.
Education
A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced degrees or certifications in regulatory affairs are highly desirable.
Experience
Applicants must have 5‑7 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to emerging markets or low‑resource settings.
Salary
The position offers a competitive salary range of SSP 30,000,000 to SSP 45,000,000 per month, commensurate with experience and qualifications.
Benefits
- Comprehensive health insurance covering employee and dependents.
- Retirement savings plan with company matching contributions.
- Annual performance‑based bonus.
- Paid parental and annual leave.
- Professional development allowance.
Training
- On‑boarding program covering Pfizer’s global regulatory processes.
- Continuous learning opportunities through internal e‑learning platforms.
- Access to industry conferences and workshops.
- Mentorship from senior regulatory leaders.
Working Environment
Pfizer provides a collaborative, inclusive, and safety‑focused workplace. Employees benefit from modern office facilities in Nimule, flexible working arrangements, and a culture that encourages innovation and teamwork. The role offers exposure to both local and international regulatory practices, fostering professional growth.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining relevant experience through the online portal on the Pfizer Careers website. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for interviews.
Equal Opportunity Statement
Pfizer is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, race, religion, age, disability, or sexual orientation. Our hiring practices support the principles of fairness and transparency, ensuring that every applicant receives equal consideration.