Regulatory Affairs Specialist Job Vacancy in Al-Fashir, Sudan – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Pfizer Inc.

Location: Al-Fashir, Sudan

Experience: 3-5 years in pharmaceutical regulatory affairs

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: SSP 150,000 – SSP 250,000 per month

Vacancies:1

Company Overview

Pfizer Inc. is a global leader in innovative medicines, vaccines, and consumer health products, operating in more than 150 countries. With a strong commitment to improving health outcomes, Pfizer has established a robust presence across Africa, partnering with local distributors, health ministries, and research institutions. In Sudan, Pfizer collaborates with the Ministry of Health and local pharmaceutical firms to ensure the availability of high‑quality medicines that address critical health challenges. The company’s culture emphasizes scientific excellence, ethical conduct, and a dedication to community impact, making it an attractive employer for professionals seeking to contribute to meaningful health solutions. As part of its expansion strategy, Pfizer is strengthening its regulatory capabilities in emerging markets, including Sudan, to streamline product approvals and maintain compliance with international standards. This role offers a unique opportunity to work within a world‑renowned organization while contributing directly to the health of Sudanese communities.

Job Overview

The Regulatory Affairs Specialist will be responsible for managing the submission, review, and maintenance of regulatory dossiers for Pfizer’s pharmaceutical products in Sudan. This includes ensuring compliance with the Sudanese National Medicines and Poisons Board (NMPB) regulations, as well as aligning with regional guidelines from the African Medicines Agency (AMA). The specialist will act as the primary liaison between Pfizer’s global regulatory team, local authorities, and internal stakeholders such as Clinical Development, Quality Assurance, and Marketing. By providing strategic regulatory guidance, the specialist will help accelerate product launches, maintain market authorization, and support post‑marketing surveillance activities. This position plays a critical role in safeguarding public health and advancing Pfizer’s mission of delivering breakthrough therapies to patients in Sudan.

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Key Responsibilities

• Prepare, compile, and submit registration dossiers for new and existing pharmaceutical products to the NMPB.
• Maintain and update product licenses, ensuring timely renewals and compliance with local regulations.
• Coordinate with global regulatory affairs teams to align Sudan submissions with international strategies.
• Monitor changes in Sudanese pharmaceutical regulations and advise internal teams on impact.
• Facilitate communication with health authorities, responding to queries and providing required documentation.
• Support post‑marketing activities, including adverse event reporting and product labeling updates.
• Develop and maintain a regulatory intelligence database for Sudan and the broader East African region.
• Collaborate with Quality Assurance to ensure product specifications meet regulatory standards.
• Participate in cross‑functional project teams to ensure regulatory considerations are integrated early in product development.

Required Skills

• In‑depth knowledge of Sudanese pharmaceutical regulations and the African Medicines Agency framework.
• Strong analytical and documentation skills with attention to detail.
• Excellent written and verbal communication in English; Arabic proficiency is a plus.
• Ability to work independently and manage multiple dossiers simultaneously.
• Proficiency with regulatory submission software and Microsoft Office Suite.
• Effective stakeholder management and negotiation abilities.

Education

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

Experience

Applicants must have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to emerging markets in Africa. Experience with electronic submission platforms and a track record of successful product registrations is essential.

Salary

The position offers a competitive salary range of SSP 150,000 to SSP 250,000 per month, commensurate with experience and qualifications. Additional performance‑based incentives may be provided.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Annual paid leave and sick leave in accordance with Sudanese labor law.
• Professional development allowance for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• On‑boarding program covering Pfizer’s global regulatory processes and local compliance requirements.
• Continuous learning opportunities through Pfizer’s internal learning platform.
• Access to external regulatory workshops and industry conferences.

Working Environment

Pfizer’s Al‑Fashir office provides a modern, collaborative workspace equipped with the latest technology to support regulatory activities. The team culture promotes knowledge sharing, innovation, and a strong commitment to ethical standards. Employees enjoy a supportive environment that values work‑life balance and encourages community involvement.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for a virtual interview. For further details about the role and the application steps, please visit our career page.

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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 race, gender, religion, age, disability, sexual orientation, or any other protected characteristic. All qualified applicants will receive consideration for employment without discrimination.