Regulatory Affairs Liaison

Location Belgium
Discipline: Biotechnology
Job type: Freelance
Contact name: Isla Littlewood

Contact email: i.littlewood@panda-int.com
Job ref: 17860
Published: 7 days ago

For one of our top Biopharma clients, we are looking for a Regulatory Affairs Liaison.

 

Responsibilities:

  • Strategic and tactical input in development, post-approval and life cycle management of small/large molecules.
  • Advise the Project Team on applicable regulatory issues.
  • Develop and ensure effective implementation of regional regulatory strategy and tactics in support of the global development and life-cycle management plan.
  • Liaison with Regulatory Agencies and Local Operating Companies - establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product specific labeling, study design, submissions content, and post-approval commitments.
  • Act as primary contact with EMEA.
  • Plan and develop briefing documents for meeting with Regulatory Agencies.
  • Advise team on required documents and submission strategies in preparation of CTA.
  • Manage submissions and advise team on required documents and submission strategies in preparation of MAAs

 

Your profile:

  • University degree - medical or paramedical (pharmacy, biology, veterinary etc.) or equivalent by experience.
  • Regulatory experience in drug development and commercialization of vaccines.
  • Experience with EU regulatory procedures (CP, MRP, national) and knowledge of the regulatory environment, guidelines and practice of EMEA regions.
  • Excellent knowledge of English.

 

Practicalities:

  • Freelance opportunity
  • Remote working opportunity
  • 20 - 25 hours (but more hours is possible)
  • Start date: as soon as possible

 

For more info, please contact Isla Littlewood at +31 20 20 44 502 or i.littlewood@panda-int.com.