Vice President, Global Regulatory Affairs

Vice President, Global Regulatory Affairs

ADC Therapeutics (NYSE) is a commercial, global leader and pioneer in the field of antibody-drug conjugates (ADCs) with specialized capabilities from clinical through commercialization.

The VP of Global Regulatory Affairs provides the strategic and operational leadership and management of the regulatory function to achieve business objectives and ensure compliance with all appropriate government regulations, industry guidelines and best practices. The role is responsible for the planning of regulatory milestones and the preparation, review and evaluation of documents for submission to regulatory authorities, including INDs and BLAs.

The position requires leadership in an evolving regulatory landscape that increasingly incorporates artificial intelligence, digital health technologies, and innovative regulatory pathways to accelerate patient access to life-saving therapies. This position reports to the Chief Medical Officer (CMO) and will be an integral member of the CMO Leadership Team (CMO-LT). The ideal candidate is able to commute to our New Providence, NJ office, twice a month or as needed.

Specific responsibilities include

Provide overall executive leadership and management in creating and executing global regulatory strategies for product development, approval and registration, novel clinical trial designs and support of future marketed products.

Develop and maintain regulatory knowledge of US, EU and all global regulations.

Manage all activities pertaining to interactions with FDA, EMA, and all other global Health Authorities (with ADCT partners as applicable) and communicate outcomes to the CMO-LT and Executive Leadership Team as requested.

Act as the primary regulatory representative on the CMO-LT and provide strategic regulatory guidance to project teams.

Lead the planning and preparation of global regulatory submissions (e.g., INDs, CTAs, Orphan Drug Applications, IND safety reports, meeting requests, and anticipated BLA submissions) and with ADCT partners as applicable.

Prepare meeting requests and briefing documents; assure team is ready for meetings / teleconferences with regulatory agencies.

Serve as the liaison between the company and FDA and other global regulatory authorities for assigned projects.

Lead the Global Regulatory Affairs organization by recruiting, retaining, and developing staff.

Establish and manage all regulatory timelines with the Global Project Manager.

Responsible for the Global Regulatory Affairs organization meeting corporate goals and objectives and keeping in compliance with applicable global policies and regulations.

Management of, and collaboration with, CRO partners for regulatory submissions and other regulatory activities as needed.

Support business development and due diligence efforts by providing technical regulatory input.

Champion adoption of emerging technologies and regulatory science initiatives to enhance operational efficiency and strategic decision making.

Oversee post-approval commitments and monitoring.

Lead product labeling and promotional material committees to review to ensure optimal content and compliance with applicable, global regulations.

What The Role Requirements Are

M.D., Ph.D., or Pharm D. degree is preferred, along with 15 years or more experience in regulatory affairs.

Strong knowledge and experience with regulatory affairs and FDA regulations, with knowledge of other key regions including EU and other international regulatory affairs (e.g., Japan and China).

Significant track record of successful interactions with US, EU and other global regulatory agencies, as demonstrated by timely submissions, management of health authority requests and approvals of drugs / biologics.

Experience in oncology and / or hematology preferred.

Experience with biopharmaceuticals is desirable.

Possess good verbal and written communication skills.

Strong experience in managing and developing people.

Must be able to work in an agile, small company environment, optimize resource allocation and be very hands-on in completion of day-to-day work.

Ability to interact effectively across boundaries with other global functions including ADCT partners.

Strong leadership in representing Regulatory Affairs positions to Executive Leadership Team.

Join Our Inclusive Team

ADC Therapeutics is proud to be an affirmative action / EEO employer. EOE minorities / females / protected veterans / disabled. We are committed to building diverse teams and fostering an inclusive, professional, and respectful work environment where employees are empowered for success.

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