Junto HLS is working directly with Sr. Regulatory Leadership at a Top 20 pharma to recruit an Associate Director, Global Regulatory Affairs.
- Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility.
- Manages direct reports to support scope of project work.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Serves as global regulatory lead on the global project team for individual project(s) of responsibility or delegates to staff with oversight.
- Collaborates with all regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
- Primary FDA contact for projects of responsibility or can delegate to staff with oversight.
- Leads the global regulatory sub team and ensures global regulatory strategy is written and executed according to plan – or oversees if delegated to staff.
- Accountable for all US FDA submissions and approvals of project(s) of responsibility or oversees direct reports responsible.
- Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieving major submissions.
- For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to management for any resource gaps for project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- 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.