Regulatory Leadership at a growing specialty pharma in California has tasked Junto HLS with recruiting a Sr. Director – Global Regulatory Team Leader reporting directly to the SVP of Regulatory, Quality and Pharmacovigilance.
- Be responsible for preparing and implementing global strategic regulatory plan for assigned product(s)
- Serve as the primary strategic regulatory interface with the Product Development Team with respect to registration strategy
- Ensure the business needs for the assigned product(s) are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all global regulatory requirements
- Be responsible for decision making necessary to ensure successful submissions and approvals worldwide
- Be responsible as the leader of the Global Regulatory Team (GRT), accountable for the overall regulatory deliverables and milestones including the Global Regulatory Strategic Plan, Regional Regulatory Management Plan, and the tactical regulatory plans required to support IND/CTA/NDA/MAA’s worldwide
- Be responsible for the global strategic regulatory interactions to support the assigned product, including: strategic imperative; reviewing strategic regulatory documents to ensure alignment with global strategic plan/messaging, and oversight of the management/conduct of the regulatory interactions globally
- Identify and implement required processes/procedures for Global Regulatory Affairs – Strategic and Liaison function as required
- Manage all Global Regulatory Leads for assigned product
- Be responsible for mentoring and coaching of Global Regulatory Leads directly and Global Regulatory Team members
- Los Angeles, CA
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.