VP (Head), N. American Regulatory Affairs

VP (Head), N. American Regulatory Affairs Location Remote, United States of America Job Type Full-time Remote Remote Description VP (Head), N. American Regulatory Affairs | Remote-based in US | Mid-Size Pharma (Rx & Gx) | RETAINED SEARCH Cornerstone Search Group has been retained by a multibillion-dollar global pharmaceutical company [with products including Innovative Rx (BLAs & NDAs), 505(b)(2)s (e.g., injectables, inhalers), Biosimilars, and Generics (ANDAs)] for a key strategic VP position that serves as the Head of their large North American Regulatory Affairs organization. In collaboration with the product strategy teams, this Vice President and their North American Regulatory Affairs (RA) organization are responsible for the implementation of regulatory strategy for the USA and Canada across the company’s entire portfolio of branded (BLA / NDA / 505(b)(2) / biosimilar) and generic products. This Head will provide oversight, counsel, and guidance to RA staff members for day-to-day operations and to RA staff and other functional areas for the planning, preparation, review, and evaluation of documents for submission to the FDA and Health Canada. This organization is responsible for ensuring that all regulatory requirements and commitments are met with respect to obtaining the approval of new products and for maintaining the approval of currently marketed products. COMPENSATION: Our client has highly-competitive compensation programs including a very attractive long-term incentive stock program. Location Our client is based on the East Coast but is open to candidates being remotely based in the US. Responsibilities KEY DUTIES AND RESPONSIBILITIES: Oversees the processes governing the preparation of major North American regulatory filings, including INDs, BLAs, NDAs, and ANDAs. Oversee the completion of the routine regulatory submissions required for the maintenance of INDs, BLAs, and NDAs, such as AE reports, annual reports, and CMC, non-clinical, and clinical amendments to INDs, BLAs, and NDAs. Provide advice, regulatory guidance, and status reports to executive leadership and other functional areas. Interpret FDA and Health Canada regulations, policies, and procedures and provide guidance on HA expectations and timelines to facilitate management decision-making and launch planning. Maintain positive relationships with the FDA as the primary liaison on submissions, communications, and specific projects. Represent Regulatory Affairs at FDA Pre-Approval Inspections. Collaborate with other global regulatory functions (i.e., regulatory operations, labeling, and policy) to ensure alignment and adoption of best practices. Provide management oversight to the Canadian Regulatory, North American Advertising and Promotion, and North American Distribution Regulatory Compliance teams. Ensure that the processes and resources are in place for the timely review of internal documentation such as change control information, method transfer packages, batch records documentation, validation protocols, and reports. Champion organizational design and associated logistical guidance to the business. Lead and drive change processes. Responsible for the operational, headcount, and capital budgets for the North America Regulatory Affairs department. DESIRED SKILLS / QUALIFICATIONS / EXPERIENCE / BEHAVIORS: 15+ years of experience in Regulatory Affairs Experience in a Regulatory Affairs leadership role where direct relationships within the FDA were built and/or maintained. Must possess strong communication, critical thinking, and interpersonal skills. Must possess expert-level knowledge and interpretation of FDA regulations and industry guidances, policies, and procedures pertaining to the submission, approval, and post-approval processes. Ability to clearly and succinctly write scientific/regulatory summaries and technical correspondence. Contact Thomas J. Fascia Email: tfascia@cornerstonesg.com Phone: 973-656-0220x717 LinkedIn: https://www.linkedin.com/in/thomasfascia Cornerstone Search Group, LLC 1200 Morris Turnpike | Short Hills, New Jersey 07078, USA www.cornerstonesg.com Recently Completed Retained Searches by Cornerstone Sample Retained Search Assignments: CEO | specialty start-up US CEO | established European small pharma CEO | CRO start-up CMO | late-stage public biotech CMO | mid-size pharma CSO | mid-size global biotech President/US Commercial Head | OSD generics SVP, Head of Global Medical Affairs | mid-size oncology company SVP, Head of Global Clinical Development | multi-TA mid-size pharma SVP, Head of Global Regulatory Affairs | late-stage Israeli biotech Group VP, Global Commercial Head | API Business Unit | Indian pharma VP, Data Science RWE | Top 5 Pharma VP, Head of Regulatory Affairs | Boston biotech VP, Head of Regulatory Affairs | NYC commercial-stage biotech VP, Head of Medical Affairs | US-based small pharma VP, Head of Clinical Development | Late-Stage British Biopharma VP, Head of Immunology Medical Affairs | Top 5 Pharma VP, Head of R&D Operations | Boston biotech VP, Head of Health Economics & Outcomes Research | Top CNS specialty pharma VP, Head of Real-World Evidence | Top 5 pharma VP, Head of Global Market Access, Pricing & HEOR | Mid-size Oncology Biotech VP, Head of Global Market Access | Top Oncology Specialty Pharma VP, Head of Heme/Onc Clinical Research | Public oncology biotech VP, Head of Global Drug Safety & PV | Chinese oncology biotech ED, Head of Clinical Operations | Series C stage British biotech ED, Global Commercial Strategy Franchise Head | Top rare disease Boston pharma ED, Head of Global Clinical Pharmacology | Public oncology biotech Medical Director, Clinical Development | Boston biotech Medical Director, Translational Medicine, Neuroscience | Top 5 Biotech AD/Director/SD levels in HEOR/RWE/Market Access – 75+ retained assignments Cornerstone's Privacy Policy Cornerstone Search Group considers all inquiries, resume submissions, and any other personal informat