Description
We are seeking a Pharmaceutical Regulatory Affairs Specialist to join our team in Rueil Malmaison, France.
The successful candidate will have a specialised diploma in Quality Regulatory Affairs and ideally in Health Law, with a PRI status being a plus.
Responsibilities:
- Manage pharmaceutical product lifecycle in regulatory, industrial, quality, and supply dimensions
- Ensure compliance with regulatory requirements and obligations of the pharmaceutical operator
- Collaborate with various functions, including medical, commercial, supply chain, regulatory, and quality
- Experience in managing supply chain disruptions, marketing suspensions, and transition strategies
- Proven crisis management, negotiation with health authorities, and mitigation plan coordination skills
- Matrix governance experience, influencing without hierarchical authority, and change management in highly regulated environments
Requirements:
- Multidisciplinary pharmaceutical and regulatory expertise
- Problem-solving, decision-making, and autonomous judgment in high-stakes situations
- Intercultural competence and English language proficiency
- Familiarity with interactions with health authorities and external stakeholders
Benefits:
- Key role in public health issues with concrete impact on patient access to treatments
- Opportunity to work on strategic projects with high stakes and international scope
- International, stimulating, and demanding environment valuing pharmaceutical expertise, autonomy, and continuous improvement
Salary Range: EUR 74,025 to EUR 123,375 per year