SUMMARY: Responsible for the strategic regulatory leadership of development projects leading to successful preparation and approval of IND/MAA and NDA submissions in a timely and efficient manner.
ESSENTIAL DUTIES AND RESPONSIBILITIES (include, but are not limited to):
- Responsible for the regulatory leadership of one or more development projects, including responsibility for regulatory strategy, IND preparation, maintenance and update activities, interaction with and preparation for key milestone meetings with regulatory agencies.
- Develops strategies to ensure the earliest possible approvals by FDA, HPB, European and other regulatory authorities.
- Provides strategic guidance on global regulatory requirements to management and project teams
- Provides guidance to senior management and department directors within Research, Preclinical and Clinical Development areas on all regulatory issues for the strategic development, planning, compilation and submission of INDs and NDA/MAAs.
- Provides regulatory guidance on strategy for proposed claims and labeling
- Represents the company by leading interactions and negotiations with regulatory agencies during all stages of development and registration
- Manages preparation of all regulatory submissions (IND/MAA/NDA)
- Reviews and approves reports and regulatory submissions
- Actively engages with stakeholder groups to help shape science based regulatory decision making.
- Acts as regulatory liaison with partner companies
- The individual must be able to critically review regulatory scientific documents across the non-clinical and clinical disciplines. The position requires a strong attention to detail and excellent verbal and written communication skills.
- The individual will have prior regulatory experience of project leadership, negotiation with and conduct of meetings with the FDA and preparation of IND and NDA submissions leading to product marketing authorization.
- The individual will possess excellent interpersonal and communication skills and will be required to effectively interact and communicate with multiple functions across the organization, including executive management.
EDUCATION and/or EXPERIENCE:
- Bachelor’s degree or equivalent in a life science plus 10 years minimum experience in regulatory affairs in the pharmaceutical/biotech industry; An advanced degree is an advantage and preferred.
- Individual must have prior project regulatory leadership experience from pre-clinical through clinical phase 3 studies, including detailed knowledge of FDA regulations and guidances for drug development, preparation and management of IND applications and prior leadership experience with NDA preparation and preferably, negotiation to marketing approval.