Education & Qualifications:
- PhD in cell biology and at least ten (10) years of progressive experience in regulatory affairs within the biopharmaceutical industry, or equivalent.
- Experience in development, manufacturing and testing of cell therapeutics is highly desirable.
- Experience with Health Canada CTA process is considered a strong plus.
- Extensive experience in preparing regulatory filings including IND/CTA, pre-NDA/BLA/MAA, and other major regulatory submissions.
- Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand impacts on regulation.
- Knowledge and understanding of international regulations and ICH guidelines related to cell therapy development.
Duties & Responsibilities:
Key responsibilities include, but are not limited to:
- Prepares briefing and regulatory documents for regulatory agencies, such as Dossiers, INDs, NDAs, and Annual reports.
- Maintains awareness of global regulatory environment for cell therapies and regenerative medicine including accelerated review programs and provides guidance and information to the Senior Management Team to ensure use of the desired regulatory strategies.
- Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in many major global markets.
- Defines country-specific regulatory strategies for all programs, assessing optimal route to approval, leading communication and negotiation with global regulatory agencies with intelligence and diplomacy, and leading the company’s effort in definitive submissions.
- Oversees quality checks, compilation, electronic processing and publishing of submissions to ensure high quality electronic submissions compliant with regulatory authority requirements.