Senior Regulatory Affairs Manager

3 days left

Attractive Package
Aug 31, 2016
Sep 28, 2016
David Nixon
Result Type
Position Type
Full Time

Regulatory Affairs Senior Manager

Regulatory Affairs Senior Manager International Regions - Geographies covered include: Canada, Middle East, Turkey, Africa & LATAM

This is an opportunity to work for a leading biotechnology companies, with global revenues in excess of $20 billion. This company has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Their focus is on R&D for novel human therapeutics to treat serious illness in the areas of oncology, haematology, inflammation, bone health, nephrology, cardiovascular and general medicine.

The Role:

The Regulatory Affairs Senior Manager is responsible for leading regulatory aspects of a product's development, blending strategic and project delivery; providing subject matter expertise for the countries in the International region to support new MAAs and Life Cycle Maintenance Activities.

Key Activities:

  • Plans and manages regulatory submissions (e.g. clinical trials, marketing applications and Lifecycle maintenance activities) for a product portfolio in compliance with filing plans and local regulatory requirements.
  • Implements product related regulatory strategies, Regulatory Affairs processes and activity planning in accordance with national legislation and regulatory requirements.
  • Provides content guidance for regional regulatory documents and meetings in accordance with strategy
  • Provides regulatory guidance on regional regulatory mechanisms to optimize product development (e.g. expediting FIH studies, Orphan Drug, Fast Track, compassionate use)
  • Manages development of the regional product label by collaborating with the regional labelling leads
  • Participates in the development, and execution of regional regulatory product strategies, including precedence, risk management and contingency planning
  • Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including response to Questions.
  • Communicates regulatory strategies within team (e.g. Global leads, local affiliates, regional teams)


  • Bachelor's degree and in-depth regulatory experience related to Canada, Middle East, Turkey, Africa & LATAM regions.
  • Knowledge of drug development Scientific / Technical Excellence
  • Team work
  • Communication skills - both oral and written
  • Ability to understand and communicate scientific/clinical information
  • Cultural awareness and sensitivity to achieve results across both regional country and International borders.

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