freelance
Regulatory Affairs Consultant Reference number: 1240
Published: 06-01-2020, 10:14
Sector: Pharmacology
6 months
Job description
One of our client in the pharmacology sector is looking for an Regulatory Affairs Consultant to support the RA in the EU region, the non-EU CES countries + Switzerland-close collaboration with the RA Liaison.
What you’ll do
  • Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
  • Liaising with Regional Submission Planner (accountable for planning in Regulatory Operations) to provide input and ensure alignment on submission plans. Collaborating closely with Regulatory Operations to establish submission timelines of Module 1 components.
  • Drafting and organizing the gathering of the module 1 components
  • Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
  • Preparing the English Product Information (Summary of Product Characteristics, label and leaflet) in collaboration with Worldwide Product Labelling
  • For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA
  • Ensuring updates to regulatory databases
  • Keep up to date with EU procedural requirements and legislation
Profile
  • Degree in life sciences
  • Minimum of 2 years experience in the pharmaceutical industry
  • Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English
Required Skills
  • Knowledge of EU regulatory procedures and development of medicinal products in general is preferred
  • Can work across boundaries: demonstrates the ability to act as intermediary across boundaries
  • Demonstrates the ability to evaluate new ideas and proposed methods for practicality and ease of implementation
  • Demonstrates ability to coordinate tasks with others for timely completion and to avoid setbacks
  • Demonstrates the ability to review regulatory documents for accuracy
  • Understands the end-to-end pharmaceutical lifecycle
  • Considers the recent innovations when formulating recommendations
  • Evaluates activities and business processes across functions, identifies areas in need for improvement and leads efforts for solution design and implementation
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