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Vice President of Regulatory Affairs
2 months ago
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 formulating global regulatory strategies and managing interactions with Health Authorities, while overseeing a growing team. This organization boasts an innovative product pipeline, a robust financial position, and a collaborative work environment.
Key Responsibilities:
- Formulate and implement global regulatory strategies for a diverse portfolio of cutting-edge 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 uphold the highest quality of submitted documentation.
- Ensure that electronic submissions and documents comply with regulatory agency and company standards.
- Collaborate with executive management to maximize the potential value of programs.
- Maintain effective relationships with external vendors.
- Oversee regulatory reviews for upcoming product launches.
- Ensure that development programs are on track to meet established objectives and timelines.
- Recruit, direct, and develop both internal and external resources to achieve program goals.
- Develop the company's quality system; create strategies for GMP, GLP, and GCP compliance, providing guidance for all clinical development initiatives.
- In collaboration with the Head of QA, manage GMP, GLP, and GCP compliance audits (domestic and international), including oversight of contract manufacturing sites, analytical testing facilities, clinical storage and distribution locations, clinical investigator sites, contract laboratories, and CROs to assess compliance status and identify risks.
- In partnership with the Head of QA, oversee QA reviews of GMP manufacturing batch records, product release and stability testing, validation reports, pharmacology and toxicology study reports, and essential clinical study documents.
- Assess compliance risks to clinical development programs and develop risk mitigation strategies.
- Establish and implement standards, policies, and procedures for GMP, GLP, and GCP compliance as necessary.
- Build a strong Regulatory Affairs and Quality team to support clinical development programs.
- Mentor and develop regulatory and quality personnel.
- Forecast budgets and establish best practices and SOPs for the department.
- Bachelor's degree in a scientific field; advanced degree (MS, PharmD, or PhD) preferred.
- 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 agencies.
- Strong experience in managing 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 necessary activities to achieve objectives.
- Experience in Quality Assurance and oversight of QA functions.
Leadership, Interpersonal, and Soft Skills:
- Demonstrated experience in leading regulatory teams.
- 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.
- Capable of 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.
- Strong communication and presentation abilities.
- Adaptable to changing circumstances; strategic thinker and problem-solver.
- Comfortable with ambiguity in a fast-paced, dynamic environment.
This is a hybrid position. Local candidates are preferred, with an expectation of being in the office a few days each week.
The budgeted salary range for this position is competitive, including an annual target bonus, equity, and comprehensive benefits. Actual salaries may vary based on factors such as skill set, experience, education, and other qualifications.
