ADC Therapeutics

Senior Director, Regulatory Affairs

ADC Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: New Providence • New Jersey • United States

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Job Level

Senior

About the role

  • 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

  • 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
  • Inclusive workplace promoting diversity and respect
  • Flexible work environment
  • Opportunities for professional development
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

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