Senior Director, Regulatory Affairs

What You’ll Do
This position leads the preparation and maintenance of INDs, BLAs, and clinical trial applications (e.g., CTR/CTAs) in compliance with US and foreign regulatory requirements and company standards. Acts as the regulatory lead on assigned project teams, providing regulatory leadership, guidance, and oversight.

Responsibilities
- Act as primary regulatory representative and provide strategic regulatory guidance to assigned project teams/sub-teams
- Lead planning and preparation of global regulatory submissions (e.g., INDs, BLAs, CTR/CTAs, Orphan Drug Applications, meeting requests, BLA submissions)
- Manage and collaborate with CRO partners for regulatory submissions
- Represent Regulatory Affairs with licensing partners
- Establish and manage regulatory timelines
- Liaison between the company and global health authorities (including FDA) for assigned projects
- Prepare meeting requests and briefing documents; develop strategies for regulatory meetings/teleconferences
- Prepare regulatory development plans
- Develop and maintain regulatory knowledge of US, EU, and ROW regulations
- Coordinate and prepare responses to regulatory agency information requests
- Interface with CMC, nonclinical, and clinical research personnel on new regulations/standards/guidance
- Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports)
- Assist in development/maintenance of departmental processes, policies, SOPs, and associated documents

Requirements / Qualifications
- 15+ years biotech/pharma research experience, including 10+ years in Regulatory Affairs
- Bachelor’s degree in scientific discipline or equivalent; PhD or Master’s preferred
- Regulatory strategic support across all phases of drug development
- Experience preparing/submitting and supporting FDA review of INDs, BLAs, or NDAs
- Oncology drug development experience strongly preferred (e.g., immuno-oncology, hematology, ADCs)
- EU regulatory experience preferred, including CTR
- Prior people management experience preferred
- Strong collaboration across stakeholders, including external CROs
- Ability to handle multiple competing tasks in a fast-growing environment
- Strong verbal and written communication skills
- Highly motivated, resourceful, able to set goals/shift priorities, work independently, and collaborate
- Good organizational skills and attention to detail

Work Location
- Remote/hybrid; travel to New Providence, NJ office required once a quarter or more as needed.