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Vice President, Global Regulatory Affairs

Reference Number: 3857
Location: NC

Our client is a global biopharmaceutical company. They have asked us to assist them in their search for a Vice President, Global Regulatory Affairs.

 

The Vice President, Global Regulatory Affairs is responsible for leading Regulatory Affairs and the development and implementation of US and EU regulatory CMC strategy. This leader provide regulatory affairs counsel to internal stakeholders, maintain the regulatory dialogue with the US FDA, and interact with internal teams and external vendors in support of US and EU regulatory filings and clinical development activities.

Major tasks and responsibilities will include:

  • Supports US FDA and EU EMA/CTA filings included pre-IND meetings, IND filings, IND yearly updates, end of phase 2 meetings, and special protocol assessment.
  • Hires, trains, and develops a high performing regulatory team.
  • Develops and owns regulatory plans and timelines. Effectively assigns and manages the team to ensure all projects are appropriately prioritized and key goals are met on time.
  • Leads the implementation of regulatory strategies and plans.
  • Guides development program planning to anticipate changes in the regulatory environment and approval requirements.
  • Ensures overall operation is within the approved budget and timeline.
  • Works effectively with a cross-functional team to achieve corporate, department, and program goals.
  • Advises program leadership and senior management on status Regulatory Affairs strategies, plans, tactics, procedures, and practices.
  • Oversees the execution of all regulatory compliance and regulatory fiscal matters within the company.
  • Advises clinical operations in the development and implementation of SOPs for clinical research/trials and related activities.
  • Develops and maintains excellent knowledge of regulatory procedures and environments; establishes and maintains an effective network with relevant policy makers, key opinion leaders, and regulatory agencies within the assigned disease area.
  • Develops and reviews sections of IND, NDA, and other global submission documents in support of clinical trials, marketing applications, and their amendments in conformance with local regulatory requirements.
  • Ensures maintenance of company’s high ethical standing.

We seek candidates with the following qualifications:

  • Bachelor’s degree in a health/life sciences or related field required
  • Must have a minimum of 15 years of pharmaceutical industry experience with increasing responsibilities in regulatory affairs.
  • Exposure to CMC Regulatory including IND, NDA required.
  • Requires proven experience and knowledge in leading and executing in bio-pharma and/or pharma organizations.
  • RAC or similar certification highly preferred.
  • Must have a solid understanding of regulatory authority guidance, including ICH.
  • Global regulatory experience required.
  • Must be able and willing to travel up to 20% as required.
  • Requires experience with regulatory filings and interactions with US FDA medical divisions and EU EMA/CTA filings.
  • Must be recognized internally and externally as an expert in regulations, guidelines, and precedents related to clinical and pharmaceutical development, labeling and promotion.
  • The demonstrated ability to develop and maintain excellent working relationships with regulatory authorities.
  • Must have current knowledge of global regulatory changes and impacts to the market.
  • Requires experience appearing before regulatory agencies and health authorities with the demonstrated ability to interact and present effectively, to anticipate and respond to questions, and to report back to senior management and colleagues.
  • The incumbent must be highly attuned on the clinical side with the ability to manage and advise, as appropriate.
  • Requires an outstanding record of managing and integrating the programs of an entire function within the Regulatory Affairs department.
  • Must have compelling interpersonal verbal, written, and presentation skills in communication with internal and external customers.
  • Demonstrated business management experience and understanding required.
  • Requires experience hiring, leading, and developing regulatory team members and enabling high performing regulatory teams.
  • Must have strong management and organizational skills with an ability to prioritize, enable, and accelerate multiple programs and projects.
  • Requires the proven agility and success in a dynamic company/business environment where change is frequent and rapid understanding and alignment is paramount.
  • The proven ability to lead organizational change is required.

If interested, please email your resume as a Word attachment to us, reference 3857.  No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.

Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.