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Executive Vice President of Regulatory Affairs

2 months ago

City of Daşşak, United States Dennis Partners Full time

This is a confidential search. Dennis Partners is a clinical stage biopharmaceutical organization focused on pioneering cancer treatment solutions. They are in search of a Senior Vice President of Regulatory Affairs to lead their Regulatory, Quality, and Medical Writing departments. Reporting directly to the President and Head of R&D, you will be responsible for shaping global regulatory strategies and managing interactions with Health Authorities while overseeing a growing team. This organization boasts a robust pipeline, a solid financial position, and a collaborative work environment. With two programs poised for FDA approval, this is an opportune moment to become part of this dynamic company.

Key Responsibilities:

  • Formulate, direct, and execute global regulatory strategies for a range of innovative oncology projects throughout all development phases.
  • Supervise and ensure the timely preparation of precise regulatory submissions, including INDs, CTAs, NDAs, and MAAs, while maintaining compliance with regulatory filing 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 uphold the highest quality of submitted documentation.
  • Ensure that electronic submissions and documents align with regulatory agency and company submission standards and technical specifications.
  • Collaborate with executive management to maximize the potential value of programs.
  • Maintain effective relationships with external vendors.
  • Oversee regulatory assessments for upcoming product launches.
  • Ensure that development initiatives are on track to meet established objectives and timelines.
  • Recruit, guide, and develop both internal and external resources to fulfill program goals.
  • Construct the company's quality system; devise GMP, GLP, and GCP compliance strategies and provide support for all clinical development initiatives.
  • In close collaboration with the Head of QA, manage GMP, GLP, and GCP compliance audits (both domestic and international), including contract manufacturing sites, analytical testing facilities, clinical storage and distribution locations, clinical investigator sites, contract testing laboratories, and CROs to assess compliance status and identify risks.
  • In partnership with the Head of QA, oversee QA evaluations of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports, and essential clinical study documents.
  • In a cross-functional capacity, evaluate all GMP, GLP, and GCP compliance risks to clinical development programs and devise and implement risk mitigation strategies.
  • Develop and enforce standards, policies, and procedures for GMP, GLP, and GCP compliance as necessary.
  • Build a proficient Regulatory Affairs and Quality team to support 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 field; advanced degrees (MS, PharmD, or PhD) are preferred.
  • A minimum of 15 years of experience in Regulatory Affairs within pharmaceutical or biotechnology companies.
  • 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 bodies.
  • Strong experience in managing successful interactions with the FDA and other health authorities.
  • Significant ex-US regulatory experience, particularly 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 engage with the executive leadership team.
  • Ability to navigate a consensus-driven environment through teamwork, trust, and shared expectations, influencing strategic direction.
  • Capability to build collaborative relationships internally and externally.
  • Ability 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 setting.

This position offers a hybrid work model. Local candidates are preferred. The budgeted salary range for this role is between $375,000 and $425,000, along with an annual target bonus, equity, and comprehensive benefits. Actual salaries may vary based on a variety of factors, including a candidate's skills, experience, education, and other qualifications.