Job ID: 7681
Job Title: Vice President, Head of Global Regulatory Affairs
Location: Remote, NJ
Retained Search
Remote Position
My client is a global, commercial-stage biotech company at the forefront of antibody-drug conjugate (ADC) innovation. With a validated technology platform, approved therapies, and a robust pipeline targeting both hematologic and solid tumors, they are transforming the cancer treatment landscape.
Position Overview: As the Vice President, Head of Global Regulatory Affairs, you will provide strategic and operational leadership across all regulatory functions to drive the company’s business objectives and ensure compliance with global health authority regulations. You will lead the planning and execution of critical regulatory milestones, including the preparation, review, and submission of INDs, BLAs, and other key filings.
The ideal candidate is a forward-thinking regulatory leader with a deep understanding of the evolving regulatory landscape, including the integration of artificial intelligence, digital health technologies, and innovative regulatory pathways that accelerate patient access to transformative therapies. This individual will also serve as a thought leader on regulatory policy and intelligence, providing strategic input to cross-functional teams.
Responsibilities:
- 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.
- Analyze international (ICH) and country-specific guidelines, national regulations, and clinical trial/marketing application procedures, and translate complex scientific/technical information into concise written documents and presentations.
- Manage all activities pertaining to interactions with FDA, EMA, and all other global Health Authorities and communicate outcomes to Executive Leadership Team as requested.
- Act as the primary regulatory representative 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 partners as applicable.
- Monitor and interpret global regulatory policy developments (e.g., FDA, EMA, ICH, WHO) relevant to Oncology product development.
- 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.
Requirements
- MD., Ph.D., or Pharm D. degree is preferred, along with 15 years or more of 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)
- Hands-on experience in leading clinical trials, Phase I-IV.
- Demonstrated success in leading and executing regulatory strategy from preclinical through development stage.
- 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 bio-pharmaceuticals 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 the completion of day-to-day work.
- Ability to interact effectively across boundaries with other global functions.
- Strong leadership in representing Regulatory Affairs positions to Executive Leadership Team.
