permanent
Regulatory Affairs consultant Reference number: 342
Published: 14-06-2018, 11:03
Region: Brussels
Sector: Pharma
Education: Bachelor
Work experience: 2 years in regulatory affairs (module 1)
Job description
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. Knowledge of EU regulatory procedures and development of medicinal products in general is preferred. Good organizational skills, proven ability to multi-task, excellent written and verbal communication skills in English.
  • • 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.
  • • Considers the recent innovations when formulating recommendations.
  • • Understands the end-to-end pharmaceutical lifecycle.
  • • 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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