Description
Report to the SVP Head of Regulatory, responsible for global regulatory strategic development. Lead, develop, and implement global regulatory strategies and provide advice on the development and life cycle management of investigational products. Prepare and manage regulatory documents, submissions, collaborating effectively with internal and external stakeholders including leading health authority interactions. Responsible for the planning, preparation, and review of content for submissions to Regulatory Agencies (e.g., INDs, CTAs, meeting requests and briefing books, IND safety reports, annual reports) and coordinate responses to Regulatory Agency requests for assigned programs, ensuring timeliness, accuracy, comprehensiveness, and compliance with regulatory standards. Provide expertise in translating regulatory requirements into practical workable plans and regulatory strategies with the team based on clinical trial data, current regulations, and regulatory landscape of competitive products. Work closely with company leadership and ensure company practices conform to Regulatory Agency requirements by establishing internal documentation, control, and validation procedures.
Previous leadership role in regulatory submissions work in the US (United States), EU (European Union), UK (United Kingdom) and APAC(Asia-Pacific). Lead meetings with global regulatory agencies for major filings like NDA (New Drug Application) and MAA (Marketing Authorization Application).
Hours/Salary
Minimum of 40 Hours / Week at $234,637.81 per year
Requirements
Experience and Education include:
- Master’s in Regulatory Affairs or foreign equivalent
- 10 years of experience (120 months) in Global Regulatory Affairs of which five (5) years of experience in filing regulatory documents related to rare diseases or with Orphan Drug designation.
