Senior Vice President of Regulatory Affairs

This is a confidential search. This clinical stage biopharmaceutical company is developing an innovative pipeline of cancer therapies. They are seeking a SVP of Regulatory to oversee their Regulatory, Quality and Medical Writing functions. Reporting into the President, Head of R&D, you will direct the development of global regulatory strategies and lead interactions with Health Authorities, while managing a growing team. This company offers an innovative pipeline, a strong cash position, and a collaborative company culture. With two programs awaiting FDA approval in 2024, now is an exciting time to join this organization!

Responsibilities:

• Develop, direct, and lead global regulatory strategies for a portfolio of innovative oncology programs across all phases of development.
• Oversee and manage the timely preparation of accurate regulatory filings, INDs, CTAs, NDAs and MAAs, and ensure the regulatory submissions required to maintain regulatory filings.
• Ensure practices are in conformance with the latest Health Authority and Industry submission standards in the US and EU.
• Lead interactions with FDA and other Health Authorities.
• Establish department standards to ensure the highest quality of submitted information.
• Ensure that electronic submissions and documents meet regulatory agency and Company’s submission standards and technical requirements.
• Partner with executive management to optimize potential value creation of programs.
• Ensure effective working relationship with vendors.
• Oversee the regulatory review for upcoming launches of multiple products.
• Ensure that development programs are progressing towards defined objectives and timelines.
• Hire, direct and develop appropriate internal and external resources to achieve program plans and objectives.
• Build the company’s quality system; formulate the company’s GMP, GLP and GCP compliance strategies and provide advice and support for all clinical development programs.
• In close partnership with the Head of QA, oversee GMP, GLP and GCP compliance audits (US and international), including contract manufacturing sites, analytical testing sites, clinical storage and distribution sites, clinical investigator sites, contract test laboratories, and CROs to determine compliance status and to identify compliance risks.
• In close partnership with the Head of QA, oversee the 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 partnership, assess all GMP, GLP and GCP compliance risks to the clinical development programs and develop and implement risk mitigation measures.
• Develop and implement standards, policies and procedures for GMP, GLP and GCP compliance as needed in addition to what is in place.
• Build a strong Regulatory Affairs and Quality team to meet the needs of the clinical development programs.
• Develop and mentor regulatory and quality staff/personnel.
• Forecast budgets and develop department best practices and SOPs.

Qualifications:

• Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
• At least 15+ years of experience in Regulatory Affairs function in pharma/biotech organizations.
• Must have strong Regulatory experience in the oncology therapeutic area.
• Must have led regulatory activities for product launches in the past.
• Demonstrated technical leadership in the successful submissions to regulatory agencies.
• Strong experience leading successful interactions with FDA and other health authorities.
• Must have strong ex-US Regulatory experience, preferably with EU/EMA.
• Demonstrated understanding of drug development and the integration of activities required to achieve goals.
• Experience in Quality Assurance and the oversight of QA function.

Leadership, Interpersonal and Soft Skills:

• Must have strong Regulatory team leadership experience.
• Strong ability to influence and gain credibility with both internal and external key stakeholders.
• Must have the gravitas and executive presence to present to executive leadership team.
• Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction.
• Ability to build collaborative relationships both internally and externally.
• Ability to inspire, motivate and develop Regulatory and Quality teams.
• Strong communication and presentation skills.
• Flexible in dealing with changing circumstances; strategic thinker and problem-solver.
• Must be flexible and comfortable with ambiguity in a fast-paced, small company environment.

This is a hybrid onsite position in the New York City area and local candidates are preferred. Must be in the office 2-3 days per week.

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 be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

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