Regulatory Affairs Specialist Job Vacancy in Wad Madani, Sudan – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: GlaxoSmithKline

Location: Wad Madani, 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 250,000 – 350,000 per month

Vacancies:1

Company Overview

GlaxoSmithKline (GSK) is a global healthcare leader dedicated to improving the quality of life through innovative medicines, vaccines, and consumer health products. With a strong presence across Africa, GSK has been operating in Sudan for over a decade, collaborating with local health authorities, distributors, and research institutions to ensure access to safe and effective pharmaceutical solutions. The company’s commitment to ethical standards, scientific excellence, and community health makes it an attractive employer for professionals seeking to make a meaningful impact. As part of its expansion strategy, GSK is strengthening its regulatory capabilities in regional hubs, including Wad Madani, to support the growing demand for high‑quality medicines in Sudan and neighboring markets. This role offers a unique opportunity to join a world‑class organization while contributing to the health and well‑being of Sudanese communities.

Job Overview

The Regulatory Affairs Specialist will be responsible for ensuring that all GSK products marketed in Sudan comply with local and international regulatory requirements. This includes preparing and submitting dossiers, liaising with the Sudanese Medicines and Poisons Board, and providing strategic guidance to cross‑functional teams on regulatory matters. The specialist will work closely with the regional regulatory hub, marketing, clinical, and quality assurance departments to facilitate product registrations, post‑approval variations, and compliance audits. The role is pivotal in maintaining GSK’s reputation for safety and efficacy, and it directly supports the company’s mission of delivering innovative health solutions to patients across Sudan. For more information about GSK’s presence in Sudan, visit the main website.

Key Responsibilities

• Prepare, review, and submit registration dossiers for new medicines, vaccines, and consumer health products in compliance with Sudanese regulations.
• Maintain up‑to‑date knowledge of local regulatory guidelines, international standards (e.g., WHO, ICH), and emerging legislative changes.
• Act as the primary liaison between GSK and the Sudan Medicines and Poisons Board, facilitating timely communication and issue resolution.
• Coordinate post‑approval activities, including variations, renewals, and pharmacovigilance reporting.
• Provide regulatory guidance to product development, clinical, marketing, and quality teams throughout the product lifecycle.
• Develop and implement regulatory strategies that align with business objectives and market access goals.
• Conduct internal audits and support external inspections to ensure ongoing compliance.
• Prepare regulatory intelligence reports and contribute to continuous improvement initiatives.

Required Skills

• Strong understanding of Sudanese pharmaceutical regulations and international regulatory frameworks.
• Excellent written and verbal communication skills in English and Arabic.
• Analytical mindset with the ability to interpret complex regulatory documents.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Effective stakeholder management and negotiation abilities.
• Attention to detail and strong organizational skills.

Education

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

Experience

Applicants must have a minimum of three to five years of hands‑on experience in regulatory affairs within the pharmaceutical industry. Experience with product registration in Sudan or other African markets, as well as familiarity with WHO pre‑qualification processes, will be viewed favorably.

Salary

The position offers a competitive salary range of SSP 250,000 to 350,000 per month, commensurate with experience and qualifications. Performance‑based bonuses and other incentives may be provided in line with GSK’s global compensation framework.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with employer contributions.
• Generous paid time off, including annual leave, sick leave, and public holidays.
• Professional development allowance for certifications, conferences, and training.
• Employee assistance program and wellness initiatives.

Training

• On‑boarding program covering GSK’s corporate values, compliance standards, and regulatory processes.
• Access to GSK’s global learning platform for continuous skill enhancement.
• Mentorship opportunities with senior regulatory leaders across the region.

Working Environment

GSK’s Wad Madani office provides a modern, collaborative workspace equipped with the latest technology to support remote and on‑site work. The company promotes a culture of inclusion, diversity, and respect, encouraging employees to share ideas and drive innovation. Employees benefit from a safe, supportive environment that values work‑life balance and encourages community engagement.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on GSK’s career site. Applications will be reviewed on a rolling basis, and shortlisted candidates will be contacted for an initial interview. For additional career resources, visit the additional website.

Equal Opportunity Statement

GlaxoSmithKline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, disability, or veteran status.