Regulatory Affairs Specialist

il y a 4 heures

Courbevoie, Île-de-France ProductLife Group Temps plein
About the Job

We are seeking an experienced Regulatory Affairs Specialist to join our team at ProductLife Group. As a key member of our Regulatory Affairs team, you will play a crucial role in the implementation of our regulatory strategy for the development and registration of oncology projects.

Responsibilities
  • Provide regulatory referrals for all requests concerning products under your responsibility.
  • Develop a regulatory strategy for products in your portfolio, evaluating local and global options in collaboration with the Regulatory Affairs Divisions.
  • Contribute to the construction of the global NCE/NBE development plan for products in your portfolio.
  • Participate in the preparation and/or revision of documents required for authorization and follow-up of clinical studies, as well as drafting responses to competent authorities and ensuring consistency of information between documents.
  • Organize and manage the preparation of meetings with local or global competent authorities.
  • Participate in the organization of due diligence aimed at establishing new partnerships for anti-cancer products.
  • Provide advice and opinions as needed to participate in the preliminary evaluation of product candidates for licensing-in in collaboration with other departments/divisions/management.
  • Prepare the regulatory analysis of product candidates for licensing-in, contribute to the development and registration strategy, and participate in the recommendation prepared for the Executive Management for the therapeutic area under your responsibility.
  • Participate in the preparation and review of relevant parts of the licensing agreement.
Profile and Skills
  • Pharmacist, PhD, or Masters in Pharmacy/Bachelor in Pharmacy.
  • 5 years of experience in Regulatory Affairs strategy/Drug development Plan, experience in oncology preferably.
  • Good scientific writing skills.
  • Fluent in English and French for daily communication.
  • Strong knowledge of RA early phase Drug development with track records in EU.
  • Team player with excellent organizational skills.
  • Ability to work both independently and in a team environment.

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