Regulatory Affairs Manager
COURBEVOIE, 92
il y a 8 jours
Shape the future of regulatory excellence at IQVIA
At IQVIA, we work to advance healthcare by helping our clients bring safe, effective medicines to patients. As a Regulatory Affairs Manager, you will play a key role in ensuring compliance and supporting successful product lifecycle management in France. You’ll collaborate with leading global pharmaceutical companies and contribute to high‑quality regulatory outcomes that truly make a difference. This is a fixed‑term opportunity for 12 months.
What You Will Do
- Manage country‑level regulatory activities for medicinal products, ensuring full compliance with local requirements.
- Prepare and coordinate regulatory submissions in partnership with internal and external stakeholders, including notifications, renewals, variations, new applications, and MAH transfers.
- Lead submission processes with local Health Authorities and follow up through approval.
- Prepare and translate product labelling into French (e.g., SmPC, PIL).
- Review and approve artwork and promotional materials in client systems.
- Support regulatory maintenance activities across multiple pharmaceutical products.
- Monitor local pharmaceutical legislation and ensure updates are applied appropriately.
What You Need To Succeed
- Bachelor of Pharmacy or other Life Sciences degree.
- 3+ years of experience in regulatory affairs for medicinal products on French market, including submission document preparation and coordination.
- Experience within a large regulatory organization, with both centralized and local activities, is an advantage.
- Excellent knowledge of pharmaceutical legislation and regulatory requirements in France.
- Excellent organizational skills, attention to detail, and ability to meet timelines.
- Strong communication skills and a collaborative working style.
- Native French and fluent written and verbal communication skills in English.
- Strong computer skills, including MS Office; experience with regulatory information systems and artwork tools is a plus.
Entreprise
IQVIA
Plateforme de publication
WHATJOBS
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