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.
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
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