Regulatory Affairs Specialist

il y a 4 semaines


Courbevoie, Île-de-France ProductLife Group Temps plein

About the Job

We are seeking an experienced Regulatory Affairs Specialist to contribute to the implementation of our regulatory strategy for the development and registration of oncology projects. In this role, you will be responsible for regulatory referrals, developing regulatory strategies, and participating in the construction of global development plans.

Responsibilities

  • Regulatory referral for all requests concerning products under your responsibility
  • Develop regulatory strategies in collaboration with the Regulatory Affairs Divisions
  • Contribute to the construction of global development plans
  • Participate in the preparation and revision of documents required for authorization and follow-up of clinical studies
  • Organize and manage meetings with competent authorities
  • Participate in due diligence for establishing new partnerships for anti-cancer products
  • Provide advice and opinions for product candidates for licensing-in
  • Prepare regulatory analysis for product candidates and contribute to development and registration strategies
  • Participate in the preparation and review of licensing agreements

Requirements

  • 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

About Us

ProductLife Group is a leading company in the development and registration of oncology projects. We are committed to delivering high-quality products and services to our clients. If you are a motivated and experienced Regulatory Affairs Specialist, we encourage you to apply for this exciting opportunity.


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