Senior Director, Regulatory Affairs

ADC Therapeutics

Senior Director leading regulatory affairs at ADC Therapeutics, focused on compliance and strategic guidance for drug development. Overseeing submissions and collaboration with project teams and regulatory bodies.

Posted 4/14/2026full-timeNew Providence • New Jersey • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Act as the primary regulatory representative on, and provide strategic regulatory guidance to, assigned project teams and sub-teams
Lead the planning and preparation of global regulatory global submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
Management of, and collaboration with, CRO partners for regulatory submissions
Represent Regulatory Affairs with licensing partners
Establish and manage regulatory timelines
Serve as the liaison between the company and global health authorities, including FDA, for assigned projects
Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies including developing strategies for such meetings
Prepare regulatory development plans for assigned projects
Develop and maintain regulatory knowledge of US, EU and ROW regulations
Coordinate and prepare responses to Regulatory Agency requests for information
Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports)
Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents

Requirements

What you’ll need

15+ years’ experience in a biotech/pharmaceutical research environment, including 10+ years in Regulatory Affairs
Minimum of a Bachelor’s degree in a scientific discipline or equivalent, with PhD or Master’s degree preferred
Experience in regulatory strategic support to all phases of drug development
Experience in preparation, submission, and FDA review of INDs, BLAs or NDAs
Experience in oncology drug development strongly preferred including, for example, immuno-oncology, hematology, ADCs and other bio-pharmaceuticals
EU regulatory experience preferred including CTR
Prior people management experience preferred
Strong verbal and written communication skills
Requires a highly motivated, resourceful, individual who can set goals, shift priorities, work independently and collaborate effectively with project teams

Benefits

Comp & perks

Inclusive workplace promoting diversity and respect
Flexible work environment
Opportunities for professional development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory submissionsINDsBLAsCTRsCTAsOrphan Drug Applicationsregulatory development plansFDA reviewoncology drug developmentEU regulations

Soft Skills

strategic guidancecollaborationcommunicationpeople managementgoal settingprioritizationindependenceteam collaborationresourcefulnessmotivation

Certifications

Bachelor's degreePhDMaster's degree