Regulatory Affairs Specialist Job Vacancy in Kairouan, Tunisia – Pharmaceuticals

Job Description

Position:Regulatory Affairs Specialist

Company:Sanofi Tunisia

Location:Kairouan, Tunisia

Experience:3-5 years in regulatory affairs within pharmaceutical industry

Education:Bachelor’s degree in Pharmacy, Chemistry, or related field; Master’s preferred

Employment Type:Full-time

Industry:Pharmaceuticals

Department:Regulatory Affairs

Salary:2500 – 3500 SSP per month

Vacancies:1

Company Overview

Sanofi Tunisia is a leading global healthcare company dedicated to improving lives through innovative medicines, vaccines, and consumer health products. With a strong presence across North Africa, Sanofi operates state‑of‑the‑art manufacturing facilities, research centers, and a robust commercial network. The company’s commitment to scientific excellence, patient‑centric solutions, and sustainable development makes it an employer of choice for professionals seeking impactful careers. As part of Sanofi’s worldwide family, the Kairouan office plays a strategic role in supporting regulatory compliance for products distributed throughout Tunisia and neighboring markets, reinforcing the company’s reputation for quality and safety.

Sanofi’s culture emphasizes collaboration, continuous learning, and diversity. Employees are encouraged to bring forward innovative ideas, engage in cross‑functional projects, and contribute to the company’s mission of “Empowering Life.” The organization invests heavily in employee development, offering access to global training platforms, mentorship programs, and opportunities to work on international regulatory initiatives. This environment fosters growth for individuals passionate about the pharmaceutical sector and eager to make a difference in public health.

Job Overview

The Regulatory Affairs Specialist will be responsible for ensuring that all Sanofi products marketed in Tunisia comply with national and international regulatory requirements. This role involves preparing and submitting dossiers, liaising with the Tunisian Ministry of Health, and supporting cross‑functional teams to navigate the complex regulatory landscape. The specialist will also monitor changes in legislation, provide strategic guidance, and contribute to the development of regulatory strategies that align with business objectives. For more information about Sanofi’s career opportunities, visit https://tunisiajobsearch.com/. This position offers a unique chance to work at the intersection of science, law, and business, playing a pivotal role in bringing life‑saving medicines to patients across Tunisia.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers for new drug applications, variations, and renewals in compliance with Tunisian regulations.
• Maintain up‑to‑date knowledge of local and international regulatory guidelines, including ICH, EMA, and WHO standards.
• Act as the primary liaison between Sanofi and the Tunisian Ministry of Health, facilitating clear communication and timely approvals.
• Collaborate with R&D, Quality Assurance, Clinical, and Marketing teams to ensure regulatory considerations are integrated throughout product development.
• Monitor legislative changes and assess their impact on existing and upcoming products, providing proactive recommendations.
• Develop and maintain regulatory intelligence databases and standard operating procedures.
• Support post‑marketing surveillance activities, including adverse event reporting and product labeling updates.
• Participate in internal audits and inspections, ensuring readiness and compliance.

Required Skills

• Strong understanding of Tunisian pharmaceutical regulations and international guidelines.
• Excellent written and verbal communication skills in Arabic, French, and English.
• Analytical mindset with the ability to interpret complex regulatory texts.
• Proficiency in regulatory submission software and document management systems.
• Detail‑oriented approach with strong organizational abilities.
• Ability to work independently and as part of multidisciplinary teams.
• Negotiation and stakeholder management skills.

Education

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

Experience

Applicants should have 3 to 5 years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with exposure to both local Tunisian submissions and international regulatory frameworks. Experience in a multinational environment is a plus.

Salary

The position offers a competitive salary range of 2500 to 3500 SSP per month, commensurate with experience and qualifications. Additional performance‑based bonuses and benefits are provided.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company contributions.
• Generous paid time off and public holiday schedule.
• Employee assistance program and wellness initiatives.
• Transportation allowance for daily commute.

Training

• Access to Sanofi’s global e‑learning platform for continuous professional development.
• On‑the‑job training in regulatory strategy and dossier preparation.
• Mentorship program pairing with senior regulatory experts.
• Opportunities to attend international conferences and workshops.

Working Environment

Sanofi Tunisia offers a modern office environment in Kairouan equipped with collaborative workspaces, meeting rooms, and state‑of‑the‑art IT infrastructure. The company promotes a flexible work culture, encouraging work‑life balance while maintaining high standards of professionalism and compliance.

Application Process

Interested candidates should submit their updated CV and a cover letter outlining their relevant experience through the online portal on the Sanofi Careers page. Applications will be reviewed by the recruitment team, and shortlisted candidates will be contacted for a preliminary interview followed by technical assessments.

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.