Director, Regulatory Affairs Operations

What You’ll Do:
This position is responsible for further developing and strategically optimizing global regulatory submissions, including preparation and maintenance of INDs, BLAs, and clinical trial applications (including CTR), and developing systems for submissions through the FDA electronic gateway. May act as regulatory lead on assigned project teams if needed.

Reporting to the Head of Global Regulatory Affairs; remote/hybrid. Travel to New Providence, NJ office once a quarter or more as needed.

Job Responsibilities:
- Act as Regulatory Information Management (RIM) system owner for all regulatory submissions (US and ex-US); establish and ensure RIM system submission of regulatory filings through the FDA ESG gateway
- Serve as ADCT responsible person for activities with the RIM vendor (system upgrades, compliance, etc.)
- Act as the “responsible person” for regional HA systems (e.g., CTIS) on behalf of ADCT while collaborating with external CROs
- Plan and prepare global regulatory submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
- 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, and clinical research personnel; keep them apprised of regulations/standards/policies/guidance impacting electronic submissions
- Maintain active INDs/CTAs/CTRs/BLAs (amendments and annual reports) from an operational perspective
- Assist in development and maintenance of departmental processes, policies, SOPs, and associated documents

Qualifications:
- 10+ years’ experience in biotech/pharmaceutical research environment, including 7+ years in Regulatory Affairs Operations
- Bachelor’s degree in a scientific discipline or equivalent; PhD or Master’s degree preferred
- Experience in regulatory operational support across all phases of drug development
- Experience preparing/submitting INDs, BLAs, or NDAs in the US and CTR/CTA outside the US
- Experience implementing and managing RIM systems and HA electronic portals (e.g., CTIS)
- Experience supporting oncology drug development programs from a Regulatory Operations perspective

Skills/Required-Preferred:
- Team player collaborating with multiple stakeholders including external CROs
- Ability to manage multiple competing tasks in a fast-growing environment
- Strong verbal and written communication skills
- Highly motivated and resourceful; sets goals, shifts priorities, works independently, and collaborates effectively
- Strong organizational skills and attention to detail