Vice President, Global Regulatory Affairs

This is an Engaged Search.  Our client is developing and commercializing targeted therapeutics to address serious unmet needs in oncology. They are seeking a Vice President, Global Regulatory Affairs to provide strategic and operational leadership for the company’s global Regulatory Affairs activities. Reporting into the Chief Regulatory and Technical Operations Officer, you will develop global regulatory strategies for their Phase III oncology program and oversee their upcoming NDA. This position is 100% remote but some regular travel to the company’s office will be required once the pandemic is over.  This company offers a close-knit, collaborative, and patient-focused culture along with competitive compensation and great employee benefits. Now is an exciting time to join this growing organization and help to get therapies for rare cancers approved!

Responsibilities:

  • Develop and lead global regulatory strategies and policies to secure approval of new targeted oncology drugs.
  • Represent company interests with health authorities, industry associations and/or other organizations for the purpose of advancing programs and ensuring compliance with legislation, regulations and/or guidelines that impact the business in the therapeutic market.
  • Oversee the preparation of company regulatory submissions including IND/CTA, IMPD and NDA strategies.
  • Oversee preparation of regulatory agency responses. Prepare for and lead meetings with the FDA and other health authorities.
  • Work closely with senior leaders from other functional disciplines to ensure that strategic business objectives are achieved through the sharing of knowledge and expertise.
  • Anticipate regulatory obstacles and emerging issues throughout the pharmaceutical product development lifecycle and develops solutions in consultation with members of regulatory and related teams.
  • Contribute to project teams by providing regulatory expertise and guidance on regulatory matters.
  • Ensure timely and high-quality execution of Regulatory deliverables through effective management of Regulatory Affairs personnel.
  • Ensure that appropriate cross-functional coordination is occurring for effective completion of Regulatory submissions and documents.
  • Provide Regulatory guidance and oversight to advocate outreach, scientific exchange, pre-approval promotion type activities and post approval advertising and promotion.
  • Recruit, develop, and mentor personnel in Regulatory Affairs.
  • Prepares Regulatory department budgets and identify appropriate external resources as needed.
  • Ensure compliance with all appropriate government regulations, industry guidelines, and best practices.

Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
  • Minimum of 15 years’ experience in the pharmaceutical/biotechnology industry with at least 10 years in Regulatory Affairs for pharmaceutical drugs.
  • Strong regulatory experience with oncology programs is required.
  • Ability to pragmatically balance strategic and operational regulatory requirements, effectively interpreting guidelines within the context of company objectives.
  • Good communicator, able to work in a diverse team, providing hands on leadership.
  • Hands-on experience with regulatory submissions including successful NDA, MAA or BLA filings.
  • Proven track record of successful interactions with FDA/EMA and other global regulatory authorities.
  • Understanding of commercial regulatory requirements as needed for advertising, promotion, medical affairs, and scientific exchange.
  • Must have strong global regulatory affairs experience (Europe, Asia Pacific, Canada, etc.)
  • Thorough understanding of the CFR and FDA/ICH guidelines and cGXP’s, as they pertain to pharmaceuticals, diagnostics and other related aspects of novel drug development.
  • Strong communication and organizational skills. Must be able to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
  • Must be comfortable working remotely and able to utilize new technologies in a remote environment.
  • Willing and able to travel to the office as needed once the pandemic is over.
  • Proven ability to hire, build, and lead a Regulatory team.
  • Strong relationship management and interpersonal skills are essential.
  • Ability to communicate effectively at all levels and present complex and/or new ideas with clarity and simplicity.
  • Natural collaborator who enjoys working on a cross-functional team.
  • Proven ability to manage multiple projects, set priorities, and meet deadlines.
  • Proven ability to lead cross-functional teams, serving as a strategic and tactical bridge between multiple areas.
  • Must be comfortable in a small company environment. Must be flexible and comfortable with ambiguity.

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