Regulatory Affairs Manager Job Vacancy in Kairouan, Tunisia – Pharmaceuticals

Job Description

Position: Regulatory Affairs Manager

Company: Sanofi Tunisia

Location: Kairouan, Tunisia

Experience: 5+ years in regulatory affairs within pharmaceutical industry

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

Employment Type: Full-time

Industry: Pharmaceuticals

Department: Regulatory Affairs

Salary: 3000 – 5000 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 that supports the delivery of high‑quality pharmaceutical solutions. The Kairouan office serves as a strategic hub for regulatory, quality, and market access activities, ensuring that Sanofi’s portfolio complies with local and international standards. As part of its commitment to excellence, Sanofi Tunisia continuously invests in talent development, sustainability, and community health initiatives, making it an attractive destination for professionals seeking rewarding career opportunities in Tunisia.

Job Overview

The Regulatory Affairs Manager will lead the preparation, submission, and maintenance of product dossiers for all pharmaceutical products marketed or under development in Tunisia. This role is pivotal in ensuring compliance with the Tunisian Ministry of Health regulations, as well as aligning with European Medicines Agency (EMA) and World Health Organization (WHO) guidelines. The successful candidate will collaborate closely with cross‑functional teams, including Clinical Development, Quality Assurance, and Commercial Operations, to drive timely product approvals and sustain market presence. For more information about Sanofi’s mission and values, visit Sanofi Tunisia Careers. This position offers a unique platform to influence public health outcomes while advancing personal expertise in regulatory science.

Key Responsibilities

• Prepare and submit registration dossiers, variations, renewals, and post‑approval changes to the Tunisian regulatory authority.
• Maintain an up‑to‑date regulatory intelligence database covering local and international guidelines.
• Coordinate with internal stakeholders to gather required data, ensuring completeness and scientific accuracy.
• Lead interactions with health authorities, responding to queries and negotiating approval pathways.
• Develop and implement regulatory strategies that align with business objectives and market timelines.
• Provide regulatory guidance during product development, clinical trials, and manufacturing scale‑up.
• Monitor and assess the impact of regulatory changes on existing product portfolios.
• Train and mentor junior regulatory staff on best practices and compliance requirements.

Required Skills

• In‑depth knowledge of Tunisian pharmaceutical regulations and international guidelines (EMA, ICH, WHO).
• Strong analytical and problem‑solving abilities with attention to detail.
• Excellent written and verbal communication skills in Arabic, French, and English.
• Proven project management capabilities, able to handle multiple dossiers simultaneously.
• Ability to work collaboratively across multidisciplinary teams and influence decision‑making.
• Proficiency with regulatory submission software and document management systems.

Education

A minimum of a Bachelor’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, or a related life‑science 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

Candidates must have at least five years of hands‑on experience in regulatory affairs within the pharmaceutical industry, preferably with a track record of successful product registrations in Tunisia or comparable markets. Experience in both generic and innovative drug pipelines is advantageous.

Salary

The role offers a competitive salary range of 3000 to 5000 SSP per month, commensurate with experience and qualifications. Additional performance‑based incentives and benefits are provided to recognize outstanding contributions.

Benefits

• Comprehensive health insurance covering employee and dependents.
• Retirement savings plan with company matching contributions.
• Generous paid time off, including vacation, sick leave, and public holidays.
• Professional development allowance for certifications, conferences, and training.
• Employee assistance program supporting work‑life balance.

Training

• Onboarding program covering Sanofi’s regulatory processes, systems, and corporate culture.
• Continuous learning opportunities through internal workshops, e‑learning platforms, and external regulatory courses.
• Mentorship pairing with senior regulatory leaders to accelerate career growth.

Working Environment

Sanofi Tunisia fosters an inclusive, collaborative, and innovative workplace where diversity of thought is celebrated. The Kairouan office provides modern facilities, flexible working arrangements, and a supportive team environment that encourages knowledge sharing and professional excellence. Employees are empowered to contribute ideas that drive both business success and societal impact.

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 on a rolling basis, 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.