VP Regulatory Affairs US

Published
October 3, 2020
Location
Brisbane, CA
Job Type

Description

Reporting to the SVP, Global Head of Regulatory Affairs, the Vice President Regulatory Affairs will manage and provide strategic leadership for regulatory strategy, agency interactions, and submissions for North America.  In conjunction with SVP, Global Head of Regulatory Affairs, and European/rest of world regulatory colleagues , s/he will be responsible for devising and implementing global regulatory strategy and providing leadership oversight for all regulatory submissions, regulatory compliance, regulatory advice and counseling in all areas of development, and commercial regulatory activities across the lifecycle of products for responsible territories. An integral part of this role is to foster strong relationships and advocacy with FDA and Health Canada as well as other international regulatory authorities, as required.  In addition, the ability to facilitate strong coordination and collaboration across internal departments and stakeholders from a global perspective is key.  This role can be located in Brisbane, CA, Durham, North Carolina (RTP) or New Jersey.

Specific Responsibilities:

  • Manage a team of US Regulatory staff including at least 4 full time staff and independent consultants, as needed
  • Act as primary strategic contact with the FDA and other regulatory agencies as applicable to enable execution of company regulatory goals
  • Provide strategic and tactical direction to drive cross-discipline consistency in regulatory approach and execution
  • Provide direct regulatory oversight to all applicable clinical and CMC activities (development and commercial).
  • Support product launch and commercialization activities
  • Provide counsel, training, and interpretation of FDA and other regulatory guidelines or issues to Company personnel and assist as a liaison between the Company and regulatory authorities
  • Keep peers and superiors apprised of expected changes to the regulatory landscape affecting existing and future Aimmune products
  • Lead the compilation, review, and submission of all North American INDs/CTAs, marketing applications and/or post approval amendments.  In addition, work closely with the European or other rest of world regulatory functions to ensure consistency and timeliness of ex US submissions.
  • Act as senior regulatory contact for ongoing alliance management functions, as required
  • Develop and design robust regulatory structures, processes and procedures and budget forecasting based on expert understanding, industry experience, and insight into future direction
  • Support medical affairs, advertising and promotion activities and corporate communication activities, including review of publications and investor relations/legal public disclosures as required
  • Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities
  • Develop and plan innovative regulatory strategies for label enhancements and life cycle product management
  • Provide regulatory strategic leadership supporting commercialization and post-marketing activities and requirements for approved products in North America
  • Provide regulatory review and approval of product labeling, promotional claims and advertising to ensure compliance with corporate policy, US and international laws and regulations
  • Ability to travel up to 25%

Qualifications / Requirements:

Education:

  • BS degree with a focus in life sciences or related; an advanced degree is preferred

Experience:

  • Minimum 15 years of experience Regulatory Affairs within the pharmaceutical industry with 7 years of specific leadership and management experience
  • Experience leading, designing, writing, and submission of regulatory filings and correspondence within a complex specialty/branded commercial pharmaceutical organization, is required
  • Experience leading the submission process for both new entities and line extensions of existing products
  • Experience supporting commercialization and post-marketing activities and requirements for approved products in North America is required
  • Strong leadership competencies and strategic business perspectives are required to ensure that sound drug development, regulatory and compliance practices are fully integrated in all clinical studies, clinical development and post-marketing activities

Other Skills and Abilities:

  • Strong understanding of the global pharmaceutical drug development and regulatory environment, particularly within the FDA.  Exposure to Health Canada and EMA a plus
  • In-depth understanding of the drug development, product commercialization and life cycle management processes combined with experience in Quality Assurance, Development, Clinical and Compliance is desired
  • Experience and/or active involvement in joint ventures, highly collaborative partnerships, and in/out-licensing business opportunities is a plus
  • Must be able assimilate and interpret trends in the US healthcare policy environment that directly affect business decisions in the pharmaceutical and biotech industry
  • Must have excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups
  • Must demonstrate a firm commitment to achieving corporate objectives while maintaining the highest ethical, regulatory and scientific standards
  • Entrepreneurial, innovative, energetic, hands-on, team oriented, and customer focused, with the ability to think strategically as well as execute project details
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