VP or SVP, Regulatory Affairs and Quality Assurance

This is a Retained Search.  Our client is developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology, dermatology and inflammatory diseases. They are seeking a Vice President or SVP of Regulatory Affairs and Quality Assurance who can oversee all Regulatory and Quality strategies for the company while building out these two functions. This role reports to the CEO and serves as a member of the Executive Team.  With multiple programs in Phase 2 trials, now is an exciting time to join this patient-focused company and help get innovative medicines approved!

Responsibilities:

  • Collaborate with senior management and cross-functional project teams to develop and lead regulatory strategies for a portfolio of small molecule drugs (for oncology, dermatology, and other indications) in the US and globally.
  • Plan and oversee activities in support of INDs, NDAs, MAAs, CTAs and other regulatory submissions.
  • Liaise directly with FDA and other regulatory agencies, including the preparation and leading of agency meetings.
  • Incorporate a global regulatory strategy into GxP compliance policies, regulatory filings, supply chain operations, marketing, sales and external partnerships.
  • Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GXP perspective.
  • Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipeline.
  • Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality by conceiving, collaborating and supporting the implementation of specific actions, processes and behaviors that support such a culture.
  • Implement, monitor and promote best practices of all Quality Assurance Systems to ensure compliance with relevant FDA and EU regulations/directives/requirements and ICH guidelines.
  • Implement a CMC strategy in the quality function via objectives and plans to ensure quality oversight, timely resolution of issues and early intervention to assure compliance.
  • Identify, resolve or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance.
  • Work with and contribute to managing external regulatory- and QA-related CROs and vendors to drive excellence and meet phase appropriate regulations and timelines.
  • Provide support, mentorship and guidance to regulatory affairs and quality assurance to ensure staff can independently make sound strategic and tactical decisions.
  • Develop the technical, GMP and leadership skills of direct reports, including performance reviews.
  • Develop processes and infrastructure that support program needs, including but not limited to SOP development and training.
  • Develop and manage departmental and study-specific budgets.

 Qualifications:

  • Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD, MD or PhD) preferred.
  • 10+ years of experience in Regulatory Affairs for pharmaceutical drugs. Some experience in Quality Assurance or Quality oversight highly desired.
  • Expert knowledge of US and global GXP regulations and guidelines, including industry best practices and standards in regulatory affairs and quality assurance.
  • Proven track record of successful NDA filings and prior drug approvals.
  • Strong Regulatory Affairs experience with Oncology, Dermatology, and/or Inflamatory Disease therapeutic areas.
  • Significant experience leading face-to-face and other formal interactions with FDA and other health authorities. Experience with Oncology, Dermatology or Pulmonology divisions of FDA required.
  • Solid experience with CMC, clinical, and nonclinical development and Regulatory submissions.
  • Ex-US or global regulatory experience highly desired.
  • Ability to interact effectively across all levels of the organizations; integrates functional expertise with business knowledge to solve problems, meet priorities and deadlines in alignment with corporate goals and objectives.
  • Must be an influential leader who possesses a cross-functional collaborative skill set.
  • Regulatory leadership and/or team management experience highly desired.
  • Demonstrated proficiency in departmental budgeting, organizing and planning.
  • Demonstrated ability to work both independently and in a team environment.
  • Excellent oral and written communication skills with strong attention to detail and the ability to coordinate and oversee multiple activities.
  • In-depth understanding of the drug development, product commercialization, and life cycle management processes.
  • Strong collaboration, leadership competencies, and strategic business perspectives are required.
  • Must be comfortable in a small company environment. Must be flexible and comfortable with ambiguity.

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