Regulatory Affairs Specialist for Oncology Project Development and Registration

il y a 3 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.

Responsibilities

  • Develop and implement regulatory strategies for oncology products, evaluating local and global options.
  • Contribute to the development and registration strategy for oncology products, including the construction of the global development plan.
  • Prepare and review regulatory documents, including authorization and follow-up of clinical studies.
  • Organize and manage meetings with local or global competent authorities.
  • Participate in due diligence for new partnerships in oncology.
  • Provide advice and opinions on product candidates for licensing-in.
  • Contribute to the regulatory analysis of product candidates for licensing-in.
  • Review and prepare relevant parts 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.
  • Ability to work both independently and in a team environment.

About ProductLife Group

ProductLife Group is a leading company in the development and registration of oncology products. We are committed to bringing innovative solutions to the market and are seeking a skilled Regulatory Affairs Specialist to join our team.

How to Apply

Please submit your application, including your resume and a cover letter, to [insert contact information].


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