Job Description
Position: Senior Pharmaceutical Regulatory Affairs Specialist
Company: Sanofi Sudan
Location: Wad Medani, Sudan
Experience: 7+ years
Education: Master’s Degree in Pharmacy or Regulatory Science
Employment Type: Full-time
Industry: Healthcare & Life Sciences
Department: Regulatory Affairs
Salary: 850,000 – 1,200,000 SSP per month
Vacancies: 1
Company Overview
Sanofi is a global leader in healthcare, dedicated to transforming the science into life-changing medicines for people around the world. As a major player in the pharmaceutical industry, our mission is to pursue medicines for 1 billion people. In Sudan, we are committed to improving healthcare accessibility and ensuring that high-quality pharmaceutical products reach the populations that need them most. We operate at the intersection of cutting-edge biotechnology and compassionate patient care, driving innovation in immunology, rare diseases, and vaccines. Our presence in the region focuses on maintaining the highest standards of safety and compliance, ensuring that every product we distribute meets rigorous international benchmarks. We are looking for dedicated professionals to join our growing team as we expand our footprint across East Africa.
Job Overview
The Senior Pharmaceutical Regulatory Affairs Specialist will play a critical role in ensuring that all Sanofi products are compliant with the local and international regulatory requirements in Sudan. This position involves managing complex submissions to the Sudan Food and Drug Authority (SFDA) and ensuring that all marketing authorizations are maintained accurately. You will act as a key liaison between the company and government health authorities, navigating the intricacies of pharmaceutical legislation to facilitate the timely launch of new therapeutic solutions. This is a high-impact role that requires a deep understanding of drug development lifecycles and a meticulous approach to documentation. For those seeking career opportunities in Sudan, this role offers a unique chance to influence public health outcomes through regulatory excellence. You can learn more about our global mission at https://sudanjobsearch.com.
Key Responsibilities
- Manage the end-to-end lifecycle of product registrations, including new drug applications and variations.
- Coordinate with the global regulatory team to ensure local compliance with international standards.
- Prepare and review technical dossiers for submission to national health authorities.
- Monitor changes in local pharmaceutical laws and provide strategic guidance to internal stakeholders.
- Oversee the labeling and packaging compliance for all products entering the Sudanese market.
- Lead inspections and audits related to regulatory compliance and product safety.
- Collaborate with the supply chain and quality assurance teams to ensure product integrity.
Required Skills
- Expert knowledge of pharmaceutical regulatory frameworks and SFDA guidelines.
- Strong analytical skills for reviewing complex technical and scientific documentation.
- Exceptional communication skills for negotiating with government officials and internal executives.
- High attention to detail regarding legal and scientific compliance.
- Project management expertise to handle multiple product lifecycles simultaneously.
- Proficiency in technical writing and scientific reporting.
Education
A Master’s degree in Pharmacy, Pharmaceutical Sciences, or Regulatory Affairs is mandatory. A PhD in a related scientific field is highly preferred. Candidates must demonstrate a strong academic background in pharmacology and medicinal chemistry.
Experience
A minimum of 7 years of professional experience in pharmaceutical regulatory affairs within a multinational corporation is required. Proven track record of successful product registrations and interactions with national health regulatory bodies is essential. Experience in the East African pharmaceutical market is a significant advantage.
Salary
The monthly salary for this position ranges from 850,000 SSP to 1,200,000 SSP, depending on experience and qualifications. This is a competitive package designed to attract top-tier talent in the region.
Benefits
- Comprehensive health and dental insurance coverage.
- Performance-based annual bonuses.
- Professional development and continuous education allowances.
- Commuter benefits and wellness programs.
- Opportunities for international mobility within the Sanofi network.
Training
- Advanced Regulatory Compliance Certification.
- Leadership and Strategic Management workshops.
- Internal Sanofi Global Quality Standards training.
- Specialized training on new biotechnology therapeutic areas.
Working Environment
The working environment is professional, fast-paced, and highly collaborative. While the role is primarily office-based in Wad Medani, it requires occasional travel to government offices and regional distribution centers. We foster a culture of integrity, scientific rigor, and continuous improvement. For more information on employment in Sudan, please visit https://zimbabwejobsearch.com/job-vacancy-in-zimbabwe/.
Application Process
Interested candidates should submit their updated CV and a cover letter detailing their regulatory experience through our official portal. We are looking for individuals who demonstrate a passion for healthcare innovation and a commitment to excellence. Please note that only shortlisted candidates will be contacted for interviews. For more job vacancies in Sudan, check our updates regularly. You can also find similar roles via https://botswanajobsearch.com/job-vacancy-in-botswana/.
Equal Opportunity Statement
Sanofi is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, or disability status.