Regulatory Affairs Specialist Job Vacancy in M’saken, Tunisia – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: GlaxoSmithKline

Location: M’saken, Tunisia

Experience: 3-5 years

Education: Bachelor’s degree in Pharmacy, Life Sciences or related field

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: 2,500 – 3,500 SSP 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 healthcare products. With a strong presence in Tunisia, GSK combines scientific expertise with a commitment to ethical standards, fostering a culture of collaboration, diversity, and continuous learning. As part of GSK’s mission, the company actively contributes to the development of the Tunisian pharmaceutical sector, creating sustainable career pathways for local talent. This role offers a unique opportunity to join a world‑class organization that values integrity, patient focus, and professional growth.

GSK’s operations in Tunisia are aligned with global best practices, ensuring compliance with international regulatory frameworks while supporting local health initiatives. The company’s strategic focus on emerging markets makes it an attractive employer for professionals seeking to make a meaningful impact on public health across the region.

Job Overview

The Regulatory Affairs Specialist will play a pivotal role in ensuring that all GSK products marketed in Tunisia meet the stringent requirements of the National Agency for the Safety of Medicines and Health Products (ANSM). This position involves preparing, reviewing, and submitting regulatory dossiers, maintaining product licenses, and acting as the primary liaison between GSK and local regulatory authorities. The specialist will also collaborate closely with cross‑functional teams, including research & development, quality assurance, and marketing, to guarantee seamless product lifecycle management.

As part of the broader GSK regulatory network, the specialist will contribute to the development of regulatory strategies that support the launch of new medicines and the maintenance of existing products. This role is essential for safeguarding product compliance, accelerating time‑to‑market, and upholding GSK’s reputation for excellence in the Tunisian market.

For more information about GSK’s global initiatives, visit the main website: https://tunisiajobsearch.com.

Key Responsibilities

• Prepare, compile, and submit regulatory dossiers for new product registrations, variations, and renewals in compliance with Tunisian regulations.
• Maintain and update product licenses, ensuring continuous market authorization.
• Act as the primary point of contact with ANSM and other relevant authorities, addressing queries and facilitating inspections.
• Collaborate with R&D, Quality Assurance, and Marketing to align product development with regulatory requirements.
• Monitor changes in local and regional regulatory legislation, providing timely updates to internal stakeholders.
• Develop and implement regulatory strategies that support product launch timelines and market expansion.
• Prepare and deliver regulatory training sessions for internal teams.
• Ensure accurate documentation and record‑keeping in accordance with GSK’s SOPs and Good Documentation Practices.

Required Skills

• In‑depth knowledge of Tunisian pharmaceutical regulations and international guidelines (e.g., ICH, EMA).
• Strong analytical and problem‑solving abilities.
• Excellent written and verbal communication skills in Arabic, French, and English.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Ability to work independently and within multidisciplinary teams.
• Attention to detail and high level of organizational skills.

Education

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced certifications in regulatory affairs (e.g., RAC, RAPS) are highly desirable and will be considered an asset during the selection process.

Experience

Candidates must have 3‑5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to the Tunisian market. Experience in preparing dossiers for both generic and innovative products is advantageous.

Salary

The position offers a competitive salary range of 2,500 – 3,500 SSP per month, commensurate with experience and qualifications. Additional performance‑based incentives and benefits are part of the total compensation package.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company contributions.
• Generous paid time off and public holiday schedule.
• Professional development budget for certifications and conferences.
• Employee assistance program and wellness initiatives.

Training

• Onboarding program covering GSK’s regulatory processes and corporate culture.
• Continuous learning opportunities through internal GSK Academy.
• Access to external regulatory workshops and industry seminars.

Working Environment

GSK provides a modern, collaborative workspace in M’saken equipped with state‑of‑the‑art technology and resources. The company promotes a flexible work environment, encouraging work‑life balance while maintaining high standards of productivity and compliance.

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 interviews.

For additional career opportunities across North Africa, explore: https://moroccojobsearch.com/.

Further details about regional job openings can be found at: https://algeriajobsearch.com/job-vacancy-algeria/.

Equal Opportunity Statement

GlaxoSmithKline is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, ethnicity, religion, disability, or sexual orientation. Our hiring practices reflect our dedication to fairness and meritocracy.