Vice President, Global Regulatory Affairs
Vice President, Global Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
Transforming what patients can expect from cancer therapy takes passion and a strong dedicated team. When you join ADC Therapeutics you will join a group of talented people who share this mission
Why ADC Therapeutics
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. Our CD-19-directed ADC for relapsed/refractory non-Hodgkin lymphoma ZYNLONTA (loncastuxamab tesirine lpyl) has received accelerated approval in the United States and conditional approval from the European Commission. ZYNLONTA is also being evaluated in combination with other anti-cancer therapeutics and in earlier lines of therapy as well as other indolent lymphomas to determine if it has potential to treat an even broader range of addition to ZYNLONTA ADC Therapeutics has a PSMA-targeting ADC in ongoing development.
We are a team of approximately 200 patient-focused purpose-driven employees with a shared mission to transform the treatment paradigm for patients. If youre interested in making a difference in the lives of patients worldwide with a team of like-minded colleagues operating in a flexible work environment come join us on our journey! To learn more about ADC Therapeutics our values and our exceptional culture please visit us at and LinkedIn.
What You Will Do
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 position 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 global 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 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 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.
Required Experience:
Chief
Employment Type
Full Time
