Global Regulatory Strategy Manager

For one of our client, a dynamic international pharmaceutical company, we are looking for a Global Regulatory Strategy Manager to work on a global international Biologic project. This is a temporary position for a 6 months contract. The position can be home based anywhere in Europe.

Responsabilities :

  • Support development and execution of global regulatory strategies for assigned indication
  • Support development and execution of global regulatory submission plans
  • Perform filing risk assessments
  • Act as member of global regulatory affairs team
  • Coordinate regulatory CMC strategies with RA CMC
  • Ensure strategic regulatory input is provided to key development activities and documents, including clinical, non-clinical, and CMC development documentation as needed
  • Identify and assess risks associated with product development and recommend strategies to mitigate these risks
  • Provide regular updates to global regulatory lead for assigned indication

Your Profile :

  • Minimum 5-10 years of biologics regulatory experience in the US/EU
  • BSc, MSc, PhD, PharmD in scientific discipline.
  • Knowledge and understanding of regulatory requirements for pharmaceutical/biological product development and approval in more than one key region (ie. US, and EU)
  • Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies
  • Experience with documenting regulatory strategies in coordination with clinical plans and marketing objectives.
  • Experience with managing service providers

For more information, feel free to contact : Noémie OLIVA: noliva@axepta.com

Noémie OLIVA

Noémie OLIVA

Team Leader & Recruitment Management Life Sciences

Morgane CAYUELA

Morgane CAYUELA

Life Sciences Recruitment Specialist

Marine DOLLAT

Marine DOLLAT

Life Sciences Recruitment Specialist

Global Regulatory Strategy Manager

Jul 16, 2021Global Regulatory Strategy ManagerWork from home anywhere in Europe Permanent Job noliva@axepta.com Life Sciences

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