Executive Vice President of Regulatory Strategy

2 weeks ago

City of Daşşak, United States Dennis Partners Full time

This is a confidential search. Dennis Partners, a clinical stage biopharmaceutical organization, is advancing a pioneering pipeline of cancer treatments. They are in search of a Senior Vice President of Regulatory Affairs to manage their Regulatory, Quality, and Medical Writing divisions. Reporting directly to the President and Head of R&D, you will spearhead the formulation of global regulatory strategies and lead engagements with Health Authorities while overseeing a growing team. This company boasts an innovative pipeline, a robust financial position, and a collaborative corporate culture.

Key Responsibilities:

  • Formulate, direct, and implement global regulatory strategies for a portfolio of innovative oncology programs across all development phases.
  • Supervise and ensure the timely preparation of precise regulatory submissions, including INDs, CTAs, NDAs, and MAAs, while maintaining compliance with regulatory requirements.
  • Guarantee adherence to the latest Health Authority and Industry submission standards in both the US and EU.
  • Lead engagements with the FDA and other Health Authorities.
  • Establish departmental standards to ensure the highest quality of submitted information.
  • Ensure that electronic submissions and documents comply with regulatory agency and company submission standards and technical requirements.
  • Collaborate with executive management to maximize potential value creation of programs.
  • Maintain effective relationships with vendors.
  • Oversee the regulatory review for upcoming product launches.
  • Ensure that development programs are advancing towards established objectives and timelines.
  • Recruit, direct, and develop suitable internal and external resources to achieve program goals.
  • Develop the company's quality system; devise GMP, GLP, and GCP compliance strategies and provide guidance and support for all clinical development initiatives.
  • In close collaboration with the Head of QA, oversee GMP, GLP, and GCP compliance audits (both domestic and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to assess compliance status and identify risks.
  • In partnership with the Head of QA, supervise QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports, and essential clinical study documents.
  • In cross-functional collaboration, evaluate all GMP, GLP, and GCP compliance risks to clinical development programs and develop and implement risk mitigation strategies.
  • Establish and implement standards, policies, and procedures for GMP, GLP, and GCP compliance as necessary.
  • Build a competent Regulatory Affairs and Quality team to meet the demands of clinical development programs.
  • Mentor and develop regulatory and quality personnel.
  • Forecast budgets and establish departmental best practices and SOPs.
Qualifications:
  • Bachelor's degree in a scientific discipline; advanced degree (MS, PharmD, or PhD) preferred.
  • 15+ years of experience in Regulatory Affairs within pharmaceutical or biotech organizations.
  • Extensive Regulatory experience in the oncology therapeutic area is essential.
  • Proven track record of leading regulatory activities for product launches.
  • Demonstrated technical leadership in successful submissions to regulatory agencies.
  • Strong experience in leading successful interactions with the FDA and other health authorities.
  • Significant ex-US Regulatory experience, preferably with EU/EMA.
  • Comprehensive understanding of drug development and the integration of activities necessary to achieve objectives.
  • Experience in Quality Assurance and oversight of QA functions.

Leadership, Interpersonal, and Soft Skills:

  • Proven experience in leading Regulatory teams.
  • Strong ability to influence and establish credibility with both internal and external stakeholders.
  • Possess the gravitas and executive presence to present to the executive leadership team.
  • Adept at managing in a consensus-driven environment through teamwork, trust, and shared expectations, influencing strategic direction.
  • Skilled in building collaborative relationships both internally and externally.
  • Able to inspire, motivate, and develop Regulatory and Quality teams.
  • Excellent communication and presentation skills.
  • Adaptable to changing circumstances; strategic thinker and problem-solver.
  • Comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid onsite position, with a preference for local candidates. The budgeted salary range for this position is US$375,000 to $425,000, plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may vary based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications.

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