Regulatory Affairs Specialist Job Vacancy in Nabeul, Tunisia – Pharmaceuticals

Job Description

Position: Regulatory Affairs Specialist

Company: Sanofi Tunisia

Location: Nabeul, Tunisia

Experience: 2-4 years in regulatory affairs within pharmaceutical industry

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

Sanofi Tunisia is a leading global biopharmaceutical company dedicated to improving health outcomes through innovative medicines, vaccines, and consumer healthcare products. With a strong presence in North Africa, Sanofi operates state‑of‑the‑art manufacturing facilities and research centers that adhere to the highest international standards. The company’s mission aligns with Tunisia’s national health objectives, fostering local talent and contributing to the economic development of the region. As part of Sanofi’s worldwide network, the Nabeul site plays a pivotal role in ensuring product quality, regulatory compliance, and market access across the Maghreb. This environment offers a dynamic platform for professionals seeking career growth in the pharmaceutical sector, making it an attractive destination for Tunisia Jobs seekers.

Job Overview

The Regulatory Affairs Specialist will be responsible for preparing, reviewing, and submitting regulatory dossiers to national and international health authorities, ensuring that Sanofi’s products meet all legal and scientific requirements. This role collaborates closely with cross‑functional teams, including Quality Assurance, Clinical Development, and Marketing, to facilitate timely product launches and maintain market compliance. The specialist will also monitor changes in legislation, provide strategic guidance on regulatory pathways, and support post‑marketing surveillance activities. Candidates will have the opportunity to work on a diverse portfolio of medicines, contributing directly to the health of patients in Tunisia and beyond. For more information about Sanofi’s commitment to innovation, visit Tunisia Job Search.

Key Responsibilities

• Prepare and submit registration dossiers for new pharmaceutical products to the Tunisian Ministry of Health.
• Maintain and update regulatory intelligence databases to track legislative changes.
• Coordinate with internal departments to gather required documentation and ensure data integrity.
• Respond to queries from health authorities and provide timely clarifications.
• Support product labeling, packaging, and advertising compliance.
• Assist in the preparation of post‑approval variations and renewals.
• Participate in audits and inspections, ensuring readiness and compliance.

Required Skills

• Strong knowledge of Tunisian pharmaceutical regulations and ICH guidelines.
• Excellent written and verbal communication in French and English.
• Analytical mindset with attention to detail and accuracy.
• Ability to manage multiple projects and meet strict deadlines.
• Proficiency in regulatory submission software and Microsoft Office Suite.
• Collaborative team player with strong interpersonal skills.

Education

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline is required. Advanced degrees or certifications in regulatory affairs are considered a strong advantage.

Experience

Applicants should possess 2‑4 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local and international submission processes.

Salary

The position offers a competitive salary ranging from 2,500 to 3,500 SSP per month, commensurate with experience and qualifications, along with performance‑based incentives.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Generous paid time off and public holiday schedule.
• Employee assistance program and wellness initiatives.
• Opportunities for international mobility and career advancement.

Training

• On‑boarding program covering Sanofi’s regulatory processes and systems.
• Continuous professional development courses in regulatory science.
• Access to internal e‑learning platforms and external certifications.
• Mentorship from senior regulatory experts.

Working Environment

Sanofi Tunisia provides a collaborative, inclusive, and safety‑focused workplace. The Nabeul office features modern facilities, flexible working arrangements, and a culture that encourages innovation and knowledge sharing. Employees are empowered to contribute ideas that drive both personal and organizational success, fostering a sense of belonging and purpose.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on our website. Applications will be reviewed by the talent acquisition team, and shortlisted candidates will be contacted for a virtual interview followed by an on‑site assessment.

Equal Opportunity Statement

Sanofi Tunisia is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees, regardless of gender, age, disability, race, religion, or sexual orientation. All qualified applicants will receive consideration for employment without discrimination.