Executive Vice President of Regulatory Affairs
2 weeks ago
This search is confidential. A clinical-stage biopharmaceutical organization is advancing a groundbreaking portfolio of cancer treatments. They are in pursuit 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 spearhead the formulation of global regulatory strategies and facilitate interactions with Health Authorities while managing an expanding team. This organization boasts an innovative pipeline, robust financial health, and a collaborative culture. With two programs poised for FDA approval, this is an exhilarating time to become part of this enterprise.
Key Responsibilities:
- Formulate, direct, and oversee global regulatory strategies for a suite of innovative oncology programs across all developmental 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 discussions with the FDA and other Health Authorities.
- Establish departmental standards to ensure the highest quality of submitted documentation.
- Ensure that electronic submissions and documents comply 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 the upcoming launches of multiple products.
- Ensure that development programs are on track to meet defined objectives and timelines.
- Recruit, direct, and develop suitable internal and external resources to fulfill program plans and objectives.
- Construct the company’s quality system; devise GMP, GLP, and GCP compliance strategies and provide guidance for all clinical development initiatives.
- In close collaboration with the Head of Quality Assurance, oversee compliance audits (both domestic and international) for GMP, GLP, and GCP, 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 Quality Assurance, 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 a cross-functional capacity, evaluate all GMP, GLP, and GCP compliance risks associated with clinical development programs and devise and implement risk mitigation strategies.
- Develop and implement standards, policies, and procedures for GMP, GLP, and GCP compliance as necessary.
- Build a robust Regulatory Affairs and Quality team to support the clinical development programs.
- Mentor and develop regulatory and quality personnel.
- Forecast budgets and establish departmental best practices and SOPs.
- Bachelor's degree in a scientific field; advanced degree (MS, PharmD, or PhD) preferred.
- Minimum of 15 years of experience in Regulatory Affairs within pharmaceutical or biotechnology 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 bodies.
- Strong experience in managing successful interactions with the FDA and other health authorities.
- Extensive ex-US regulatory experience, preferably with EU/EMA.
- Deep 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 leadership experience in managing regulatory teams.
- Strong ability to influence and build credibility with both internal and external stakeholders.
- Possess the gravitas and executive presence to engage with the executive leadership team.
- Ability to operate in a consensus-driven environment through teamwork, trust, and shared expectations, influencing strategic direction.
- Capability to cultivate collaborative relationships both 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 environment.
This position operates in a hybrid model. Local candidates are preferred, with an expectation of being in the office a few days each week.
The anticipated 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 factors such as skill set, experience, education, and other qualifications.
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