Vice President, Regulatory Affairs

Position Summary

The Vice President of Regulatory Affairs leads, directs, and implements the regulatory strategy for the Company. The VP is responsible for regulatory strategy and recommendations to the CMO and Research and Development Leadership Team (RDLT) and for identifying the key strategic regulatory drivers for early and late-stage programs from IND/CTA to NDA/BLA/MAA. The VP is also responsible for developing, establishing, and maintaining effective relationships with worldwide health authorities, including FDA and EMA, and oversees all Regulatory Affairs (RA) activities through both early and late-stage development, licensure, and commercialization in the US, Europe, and other regions.

The VP is a critical member of the early- and late-stage Product Development Team (PDT) and Research and Development Leadership Team (RDLT) and works to drive proactive identification and resolution of drug development project issues.

This position is remote with a corporate headquarters in Foster City, CA and Parsippany, NJ. The Vice President will report to the Executive Vice President, R&D and Chief Medical Officer.

• Build and retain highly effective team of regulatory professionals, and through leadership and direct line management, facilitates personal development and training of team members to ensure successful execution of global regulatory activities and strategies for the Company's product development programs
• Leadership of cross-function teams where appropriate to achieve corporate goals, especially where regulatory activities form a significant contribution
• Develop and implement RA strategies and plans during clinical development and in preparation for the anticipated registration filings, including ODD and PIP strategies
• Identify and assess regulatory risks, including regional and global market-related drivers
• Lead and oversee regulatory submissions for hematology/oncology products, including health authority communication strategies
• Implement and integrate best regulatory practices into pre-clinical, clinical, and CMC submissions and ensure that all regulatory submissions are appropriately reviewed, complete, scientifically accurate, and of high quality
• Lead responses to and/or resolution of regulatory inquiries from agencies and health authorities and represents RA at meetings and interactions with regulatory agencies
• Contribute to the creation of development plans that incorporate regulatory strategies designed to maximize the likelihood of successful regulatory applications, delivering regulatory approval, advantageous labeling, and reimbursement for all key indications
• Serve as a credible, influential, respected Company spokesperson during interactions with US and ex-US regulatory agencies and drive appropriate, proactive communications to assure expedient and efficient review and approval of submissions
• Monitor and anticipate regulatory and scientific advances, novel endpoints, innovative clinical trial designs, and regularly brief Company management
• Lead the preparation and management of timely regulatory submissions, including INDs, briefing documents, clinical protocols, NDAs/MAAs, fast-track, breakthrough designation, accelerated approval, and orphan drug applications
• Fulfill all requirements for ensuring reporting obligations are met, including amendments, annual reports to FDA, safety, and quality reports
• Lead and contribute to process improvement initiatives, and development of department SOPs
• Collaborate with clinical and drug safety to manage the regulatory aspects of the Company systems, and providing the regulatory oversight and reporting requirements
• Review and approval of clinical study protocols, CSRs, SAPs, DSUR, IBs, and ISS
• Collaborate on the preparation of regulatory submissions, including post-marketing commitments, safety updates, and payer evidence packages as part of RDLT;
  Collaborate with Manufacturing and Quality to manage regulatory aspects of all CMC activities, including regulatory evaluation of CMC change controls
• Assess and align the organization to meet the goals of the long-range business plan
• Represent the Regulatory department in internal…