ADC Therapeutics

Director, Regulatory Affairs Operations

ADC Therapeutics

full-time

Posted on:

Location Type: Hybrid

Location: New Providence • New Jersey • United States

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Job Level

Lead

About the role

  • This critical position is responsible for further developing and strategically optimizing global Regulatory submissions leading the preparation and maintenance of INDs, BLAs and clinical trial applications (including CTR)
  • Developing systems for submissions through the FDA electronic gateway
  • Acting as the regulatory lead on assigned project teams if needed
  • Reporting to the Head of Global Regulatory Affairs
  • Act as the Regulatory Information Management (RIM) system owner with associated tasks linked to this function for all regulatory submissions (US and ex-US)
  • Ultimately be accountable for establishing the RIM system to submit regulatory filings through the FDA ESG gateway
  • Acts as the ADCT responsible person for all activities with the RIM vendor (system upgrades, compliance etc)
  • Collaborate with the Regulatory Lead to plan and prepare global regulatory submissions from a Regulatory Operations perspective (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications)
  • Collaborate with CRO partners for global regulatory submissions
  • Establish and manage regulatory timelines
  • Prepare meeting requests and briefing documents, 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 and electronic submissions
  • Maintain active INDs/CTAs/CTRs/BLAs (amendments and annual reports) from an operational perspective
  • Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents.

Requirements

  • 10+ years’ experience in a biotech/pharmaceutical research environment, including 7+ years in Regulatory Affairs Operations
  • Minimum of a Bachelor’s degree in a scientific discipline or equivalent, with PhD or Master’s degree preferred
  • Experience in Regulatory Operational support to all phases of drug development
  • Experience in the preparation, submission, of INDs, BLAs or NDAs in the US and CTR/CTA outside of the US
  • Experience in implementation and management of RIM systems, and HA electronic portals (eg CTIS)
  • Experience in supporting oncology drug development programs from a Regulatory Operations perspective
  • Team player who can collaborate and work successfully with multiple key stakeholders including external CROs
  • Ability to successfully handle multiple, competing tasks in a fast-growing company environment
  • 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
  • Good organizational skills and attention to detail.
Benefits
  • Health insurance
  • Flexible work arrangements
  • Professional development opportunities
Applicant Tracking System Keywords

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

Hard Skills & Tools
Regulatory submissionsINDsBLAsCTRsCTAsRIM systemsFDA electronic gatewayRegulatory Operational supportOncology drug developmentHA electronic portals
Soft Skills
collaborationcommunicationorganizational skillsattention to detailability to handle multiple tasksgoal settingresourcefulnessindependenceteam playerstakeholder management
Certifications
Bachelor’s degreePhDMaster’s degree