Junto HLS is working directly with Sr. Regulatory Leadership at a Top 20 pharma to recruit a Senior Manager, Global Regulatory Affairs.
- Working with global lead as needed in leading the regulatory working team; ensures global regulatory strategy is written and executed according to plan for assigned projects.
- Manage all relevant submissions and approvals for project(s) of responsibility.
- Accountable for ensuring all other regulatory submissions outside of region are submitted on schedule by local affiliates.
- Responsible for achieving submission of INDs, CTAs, briefing packages, responses, and other submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
- For the project(s) of responsibility, collaborates with global and other regional counterparts ensuring critical deliverables to territories are provided outside of region to ensure regional execution of the strategy as agreed within the global regulatory strategy.
- May develop/author for less complex programs or assist Global Regulatory Lead with development of global regulatory strategy.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Generally serves as regulatory lead on the global development team for individual project(s) of responsibility. Collaborates with all regions to ensure a global regulatory strategy is created and executed upon for all projects within project(s) of responsibility.
- Generally the primary regulatory authority contact for project(s) of responsibility.
- Direct point of contact with health authorities on general issues.
- Supports and attends regulatory authority and other agency meetings and can lead with oversight.
- Ensure regulatory compliance of marketed products.
- May manage associate level regulatory personnel.
- As assigned, is responsible for “due diligence” activities for evaluation of possible in-licensing compounds in area of therapeutic responsibility
- As assigned, is responsible for regulatory evaluation portion of feasibility assessments of pipeline candidates.
- 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.