VP or SVP of Regulatory, Quality & Medical Writing

This commercial-stage biopharmaceutical company is advancing innovative cancer therapies. They are seeking a Senior Vice President to oversee their Regulatory, Quality, and Medical Writing functions. Reporting into the Head of Research & Development and Chief Medical Officer, you will guide the development of global regulatory strategies and manage three exceptional teams. This company offers a strong cash position, and a collaborative, patient-focused company culture. With two approved products and an innovative pipeline, now is an exciting time to join this organization!

Responsibilities

Oversight responsibility for the Regulatory, Quality, and Medical Writing functions.

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.

Ensure that electronic submissions and documents meet regulatory agency and Company’s submission standards and technical requirements.

Ensure effective working relationship with electronic submissions vendor.

Review or establish department standards to ensure the highest quality of submitted information.

Oversee the life cycle management of electronic submissions.

Ensure that development programs are progressing towards defined objectives and timelines.

Partner with executive management to optimize potential value creation of the company’s programs.

Hire, direct and develop appropriate internal and external resources to achieve program plans and objectives.

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.

Oversee Medical Writing team.

Forecast and manage budgets for the Regulatory, Quality and Medical Writing functions.

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 across all phases of development from pre-clinical to post-approval.

Demonstrated technical leadership in the successful submissions to regulatory agencies of: INDs in e-CTD format, IMPDs, CTAs, NDA, MAAs, BLA/Supplements, Periodic Safety Update Reports, etc.

Strong experience leading successful interactions with FDA and other health authorities.

Must have strong ex-US Regulatory experience, preferably with EU/EMA and MHRA.

Demonstrated understanding of drug development and the integration of activities required to achieve goals.

Experience in Quality Assurance and the oversight of QA function preferred.

Regulatory Affairs Certification (RAC) preferred.

Leadership, Interpersonal and Soft Skills

Must have strong Regulatory team leadership experience.

Oversight of Quality Assurance and/or other functions a plus.

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 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 remote position with some travel required. East Coast candidates are highly preferred.

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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