VP (Head), N. American Regulatory Affairs
Description
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
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 information submitted to us as confidential information. This information will not be shared with any parties outside of Cornerstone Search Group without your prior permission.