Job Description
Position:Regulatory Affairs Specialist
Company:United Nations Development Programme (UNDP)
Location:Kassala, 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:120,000 – 180,000 SSP per month
Vacancies:1
Company Overview
UNDP, the United Nations Development Programme, is a global leader in fostering sustainable development, democratic governance, and resilient societies. With a strong presence in Sudan since 2005, UNDP collaborates with government agencies, civil society, and the private sector to implement projects that improve health, education, and economic growth. The organization’s commitment to innovation and capacity building makes it an attractive employer for professionals seeking to make a meaningful impact. As part of its expanding health portfolio, UNDP creates exciting Sudan Jobs and supports Hiring in Sudan.
Job Overview
The Regulatory Affairs Specialist will ensure that pharmaceutical products imported, manufactured, or distributed in Sudan comply with national and international regulations. Reporting to the Senior Regulatory Affairs Manager, the incumbent will coordinate with the Ministry of Health, local manufacturers, and international partners to prepare dossiers, conduct compliance audits, and support market authorization processes. This role offers a unique opportunity to contribute to public health outcomes while advancing your career in a dynamic, multicultural environment. The position aligns with Career Opportunities in Sudan and supports broader Employment in Sudan goals.
Key Responsibilities
- Prepare and submit registration dossiers for pharmaceutical products in accordance with Sudanese regulations.
- Conduct regulatory gap analyses and recommend corrective actions to ensure compliance.
- Liaise with the Sudanese Ministry of Health and other regulatory bodies to facilitate product approvals.
- Monitor changes in national and international pharmaceutical regulations and update internal policies.
- Provide regulatory guidance to product development and quality assurance teams.
- Develop and maintain a regulatory information database for all active products.
Required Skills
- In‑depth knowledge of Sudanese pharmaceutical regulations and WHO guidelines.
- Strong analytical and documentation skills with attention to detail.
- Excellent communication in English; Arabic proficiency is an advantage.
- Proficiency in regulatory software tools and Microsoft Office Suite.
- Ability to work independently and within multidisciplinary teams.
- Project management experience with timeline and deliverable tracking.
Education
A Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, or a related discipline is required. A Master’s degree or professional certification in Regulatory Affairs (e.g., RAC) is highly desirable and will be considered an asset during the selection process.
Experience
Applicants must have at least three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to emerging markets and familiarity with the Sudanese regulatory environment.
Salary
The position offers a competitive salary ranging from 120,000 to 180,000 SSP per month, commensurate with experience and qualifications, along with a comprehensive benefits package.
Benefits
- Health insurance covering the employee and eligible dependents.
- Annual leave and sick leave in accordance with UNDP policies.
- Professional development allowance for certifications and conferences.
- Retirement savings plan with employer contributions.
- Flexible working arrangements to support work‑life balance.
Training
- Orientation program on UNDP’s mission, values, and operational procedures.
- Regulatory affairs workshops led by senior experts.
- Access to online courses on international regulatory standards.
- Mentorship from experienced regulatory professionals within UNDP.
Working Environment
UNDP provides a collaborative and inclusive workplace where diversity of thought is celebrated. Employees work in modern office facilities in Kassala, with reliable internet, meeting rooms, and a supportive administrative team. The organization encourages a healthy work‑life balance and promotes a culture of continuous learning and innovation.
Application Process
Interested candidates should submit their application through the UNDP career portal. Please upload your CV, cover letter, and copies of relevant certifications. For detailed job specifications and to apply online, visit https://sudanjobsearch.com. Additional information about UNDP’s work in Sudan and other regional opportunities can be found at https://www.senegaljobsearch.com/. Applications will be reviewed on a rolling basis until the position is filled.
Equal Opportunity Statement
UNDP is an equal opportunity employer. We welcome applications from all qualified individuals regardless of gender, ethnicity, religion, disability, or sexual orientation. Our commitment to diversity and inclusion ensures a fair and supportive recruitment process for all candidates.