Vice President, Regulatory Affairs (SF Bay Area)

The Vice President, Regulatory Affairs will report directly to the Senior Vice President, Clinical and Regulatory Affairs. Main responsibilities include: Devise overall regulatory strategy to attain rapid regulatory approvals. Ensure strategies are successfully executed, proactively modifying strategy and actions to adjust to environmental changes. Serve as main liaison with the FDA for a strong and effective relationship with the agency, specifically with the pulmonary and neuropharmacology groups at CDER. Manage the regulatory team, and provide direction on objectives, execution and prioritization. Formulate, approve or appropriately modify the existing regulatory strategy. Provide input into preclinical research to ensure that the proper information for future IND’s and NDA’s is available. Identify emerging regulatory issues and recommend potential solutions to Executive. Attend relevant meetings and events to ensure that regulatory therapy area knowledge is comprehensive and up to date.

Requirements:

PROFESSIONAL QUALIFICATIONS



• A strong and credible expert with a good reputation among peers, with the FDA and other Global Regulatory Institutions. A dynamic and established leader with strong team building skills. Additional proven experience as a strong technical contributor would be an asset.

• 15+ years of progressively increasing regulatory experience in the pharmaceutical.

• Hands on experience and a proven track record of successes in pulmonary and/or neurological drug submissions (e,g. NDA, IND, MAA) is necessary. Successful filing and approval of at least one NDA in either pulmonary of neurology. Device experience is a plus.

• Have a thorough knowledge and keen understanding of U.S. Food and Drug Law, ICH Guidelines and GCPs. Possess ability to apply and integrate the regulatory and compliance experience into business strategy.

• Proven knowledge and a successful track record in related areas such as clinical research, medical affairs/safety, quality, product development and risk management.

• An advanced degree, Ph.D., M.D. or Pharm.D. is preferred.

• Extensive experience in regulatory processes throughout the entire product life cycle is essential; experience in pulmonary and neurology and relationships with the appropriate CDER divisions is highly desirable.

• Experience in pre-NDA FDA meetings preparation and attendance, as well as preparation for ODAC meetings is highly desirable.

• Possess a track record of skillfully managing and completing projects on time and within budget.

• Experience in supervising regulatory personnel, budgeting, organizing, and planning for a growing regulatory department supporting multiple products and marketing activities.

• Ability to establish and meet priorities, deadlines, strategic department goals and objectives.

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