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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.
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Entreprise
IQVIA
Plateforme de publication
WHATJOBS
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