Description:
The Associate Director will be a strategic leader within the Global Regulatory Strategy, Oncology group. They will be responsible for developing and executing regulatory plans for the US market and ex-US regions for assigned programs at various stages of product development. They will be relied upon to articulate clear and compelling regulatory strategy and highlighting risks and opportunities when appropriate. Prior regulatory experience with oncology drug development is strongly desired.
Here’s What You’ll Do
- Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL
- Sets strategic direction for the US market, in collaboration and alignment with the global product strategy with GRL, Global Regulatory Sub-Teams and project teams for assigned programs.
- Ensures the US regulatory strategy is aligned with the global strategy for assigned programs, including for investigational new drug application submissions.
- Leads the strategy for US FDA interactions with the cross functional team, including development of content, format and accountability for regulatory submissions and related supplements and amendments, FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plans, DSURs, etc.
- Conducts risk assessment and identifies potential areas of regulatory concern for assigned projects or programs and responds to emerging health authority regulations and requirements.
- In collaboration with the cross functional team, leads the response to health authority requests for additional data, organizes and manages participation in meetings relevant to aspects of compound development
- Reviews and may approve regulatory documents prior to submission to respective regulatory authority(ies).
- Serves as primary point of contact and negotiates directly and effectively with FDA and other health agencies for assigned programs.
- May serve as regulatory affairs representative to provide input on clinical trials and filing activities and to ensure that report systems are maintained and compliant.
- Identify areas in need of improvement and lead the development and implementation of process improvements.