Junto HLS has been engaged by Regulatory Leadership at a Top 20 pharma to recruit a Senior Director, Regulatory Affairs.
- Provides regulatory oversight for multiple projects covering a minimum of one highly active therapy area, focused on non-clinical and clinical aspects of drug development and associated regulations.
- Provides leadership and training for multiple direct reports including those that serve as GDT regulatory leads responsible for the design and execution of global regulatory strategies in collaboration with their regional counterparts.
- Collaborates with all regional counterparts to ensure a global regulatory strategy is created and executed upon for all projects within therapeutic area of responsibility.
- Oversee regulatory guidance feedback to competent authorities and provide interpretation to the business
- Oversees and accountable for all relevant submissions and approvals within therapeutic area of responsibility for assigned programs.
- In collaboration with global affairs, works to resolve regional critical conflicts in global regulatory strategies and oversee critical deliverables outside of region as agreed within the global regulatory strategy.
- Approves global regulatory strategies and authors for more complex regulatory strategies as needed; oversee execution, generally delegates to staff.
- Leads and manages meetings with regulatory authorities and agency meetings; or delegates and oversees direct reports; negotiates on behalf of project team as necessary.
- Lead interactions with health authorities, delegate to staff for general interactions.
- Proactively builds/strengthens external stakeholder (Regulatory Agency, external experts, industry organizations, etc) contacts/influence to achieve company strategic goals and objectives.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies regulatory requirements and trends across therapeutic area(s) of responsibility, and provides regulatory guidance, and expertise to global development team and/or higher governance bodies in these areas.
- 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.