Junto HLS has been exclusively engaged by Regulatory Leadership at a Top 20 pharma to recruit an Associate Director, Regulatory Affairs Strategy.
- This position will serve as the FDA Point of Contact for a priority Phase 2 program
- Important upcoming milestones and activities
- Meeting requests, briefing docs and ultimately the BLA
- Will be involved in MLR aspects as well
- Work on impactful, life-saving medications, well positioned vs. unmet medical need and competitors
- Company has products at each stage of development – from Phase 1 through Phase 3
- This position will also support a separate initial BLA filing
- Opportunity to gain Regulatory experience with CBER
- Responsible for regulatory activities supporting the development of candidates in the US and Canada.
- Leads and manages health authority meetings as applicable for specified projects.
- Acts as primary regulatory authority contact for projects of responsibility.
- Accountable for overall content and management of local regulatory components and filings i.e. NDA/BLAs, INDs. Contribute to overall strategy and content for local label development.
- Acts as US regulatory content and procedural subject matter expert to internal stakeholders on matters related to regulatory affairs activities in the US and Canada.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Ensures that all necessary applications are filed and maintained in compliance with applicable regulations.
- Leads and directs the work of others as part of a matrixed organization.
- Greater Boston, MA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.