Regulatory Affairs Specialist Job Vacancy in Dongola, Sudan – Pharmaceuticals
Job Description
Position: Regulatory Affairs Specialist
Company: Novartis
Location: Dongola, 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 – 250,000 per month
Vacancies:1
Company Overview
Novartis is a global leader in innovative medicines, dedicated to improving health outcomes worldwide. With a strong presence across Africa, Novartis operates in Sudan through a network of local partners, ensuring access to high‑quality pharmaceutical products for patients in remote and urban areas alike. The company’s commitment to scientific excellence, ethical standards, and sustainable development makes it a premier employer for professionals seeking to make a meaningful impact. As part of its expansion strategy, Novartis is establishing a regulatory hub in Dongola to streamline product approvals, maintain compliance with Sudanese health authorities, and support the growing demand for advanced therapies. This initiative creates exciting Sudan Jobs and reinforces Novartis’s role in shaping the future of healthcare in the region.
Job Overview
The Regulatory Affairs Specialist will serve as a key liaison between Novartis, the Sudanese Medicines and Poisons Board, and other regulatory bodies. You will be responsible for preparing, submitting, and tracking dossiers for new drug registrations, variations, and renewals, ensuring that all documentation meets local and international standards. The role involves close collaboration with cross‑functional teams, including Clinical Development, Quality Assurance, and Marketing, to align regulatory strategies with business objectives. This position offers a unique opportunity to contribute to the health sector while advancing your career within a multinational environment. For more information about Novartis’s presence in Sudan, visit the main portal.
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Key Responsibilities
- Prepare and compile comprehensive regulatory submissions for new drug applications, line extensions, and post‑approval changes.
- Maintain an up‑to‑date regulatory intelligence database covering Sudanese and regional guidelines.
- Coordinate with internal stakeholders to gather required data, ensuring accuracy and completeness of dossiers.
- Interact directly with the Medicines and Poisons Board to address queries, provide clarifications, and negotiate timelines.
- Monitor and interpret changes in local legislation, advising senior management on impact and required actions.
- Develop and implement standard operating procedures (SOPs) for regulatory activities to ensure compliance.
- Support product labeling, packaging, and advertising reviews to meet regulatory requirements.
Required Skills
- In‑depth knowledge of Sudanese pharmaceutical regulations and ICH guidelines.
- Excellent written and verbal communication skills in English and Arabic.
- Strong analytical abilities with attention to detail for dossier preparation.
- Proficiency in regulatory software tools and Microsoft Office suite.
- Ability to work independently and manage multiple projects under tight deadlines.
- Effective stakeholder management and negotiation skills.
Education
A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related discipline is required. Candidates holding a Master’s degree or professional certifications such as RAC (Regulatory Affairs Certification) are highly regarded. Continuous learning and staying abreast of evolving regulatory landscapes are essential for success in this role.
Experience
Applicants should possess 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to African markets. Experience in preparing Common Technical Documents (CTD) and interacting with health authorities will be considered a strong advantage.
Salary
The compensation package ranges from SSP 150,000 to SSP 250,000 per month, commensurate with experience and qualifications. The package includes performance‑based bonuses, health insurance, and other statutory benefits.
Benefits
- Comprehensive health and dental coverage.
- Retirement savings plan with employer contributions.
- Annual performance bonus linked to individual and company targets.
- Paid annual leave and sick leave in accordance with Sudanese labor law.
- Opportunities for international assignments and career progression within Novartis.
Training
- On‑boarding program covering Novartis’s regulatory processes and corporate culture.
- Access to e‑learning platforms for continuous professional development.
- Mentorship from senior regulatory experts across the global network.
- Attendance at regional regulatory conferences and workshops.
Working Environment
Based in Dongola, you will work in a modern office equipped with the latest technology, fostering collaboration and innovation. Novartis promotes a diverse and inclusive workplace where ideas are valued, and employees are encouraged to contribute to the company’s mission of improving health outcomes.
Application Process
Interested candidates should submit their updated CV and a cover letter outlining their suitability for the role through the Novartis career 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.
Equal Opportunity Statement
Novartis 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 reflect our dedication to fairness and respect, ensuring that every applicant receives an unbiased evaluation.
