Senior Regulatory Affairs Manager
3 days left
- 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 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.
- 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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