ID-Clinical - personnel resourcing specialists for the Pharmaceutical, Biotechnology and Clinical Research industry.

ID-Clinical Candidates Job - Regulatory Affairs Manager

Reference IDSS000101DP
Title Regulatory Affairs Manager
Description Our client is focused on supporting biotech and pharmaceutical companies at every stage of the product lifecycle, from first-into-human studies to product launch and beyond.

This is a new role due to continued expansion and offers a first class opportunity to excel in a position that will grow with the business.

Responsible for conducting a range of EU regulatory activities for clients, key tasks will include:

  • Preparation and/or review of IMPDs to ensure relevant data are included and presented in a clear manner
  • Working with Clinical colleagues to ensure all other documents required for submission of CTAs to National Competent authorities are available in an appropriate time frame and meet regulatory requirements
  • Preparation of responses to any issues that arise on CTA applications
  • Preparation of EU Scientific advice briefing books
  • Managing the logistical aspects of agency meetings and submissions for Scientific Advice and Orphan Drug Designations
  • Contributing to the preparation of MAAs

Candidate Requirements

  • At least a B.Sc in a relevant discipline with a preference for a Pharmacist
  • Minimum of 3 years regulatory experience or equivalent knowledge preferably gained in a CRO
  • Scientific writing experience ie experience of writing documents like an IMPD
  • Hands on experience of CTAs across multiple countries and EU Scientific advice procedure
  • Experience with, and interest in, CMC aspects of regulatory applications
  • Excellent IT skills preferably with experience of dossier publishing tools
Salary Excellent package offered
Location Europe, UK, Hertfordshire

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