Senior Director Regulatory Affairs
ADC Therapeutics
9 hours ago
Remote friendly (New Providence, NJ)
United States
Corporate Functions
What You’ll Do:
- Lead preparation and maintenance of INDs, BLAs, and clinical trial applications (e.g., CTR) compliant with US, foreign regulatory requirements, and company standards.
- Serve as regulatory lead on assigned project teams, providing regulatory leadership, guidance, and oversight.
- Support global regulatory activities; remote/hybrid role with some travel to the New Providence, NJ office once a quarter or more as needed.
Job 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.
- Liaise between the company and global health authorities (including FDA).
- Prepare meeting requests and briefing documents; develop meeting strategies and ensure team readiness.
- Prepare regulatory development plans.
- Develop and maintain knowledge of US, EU, and ROW regulations.
- Coordinate and prepare responses to regulatory agency requests for information.
- Interface with CMC, nonclinical, and clinical personnel; communicate relevant new regulations/standards/policies.
- Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports).
- Assist in developing and maintaining departmental processes, policies, SOPs, and related documents.
Who You Are (Qualifications):
- 15+ years’ biotech/pharma research experience, including 10+ years in Regulatory Affairs.
- Bachelor’s degree in a scientific discipline or equivalent (PhD/Master’s preferred).
- Experience in regulatory strategic support across all phases of drug development.
- Experience preparing, submitting, and supporting FDA review of INDs/BLAs/NDAs.
Preferred Skills/Experience:
- Oncology drug development experience (e.g., immuno-oncology, hematology, ADCs, bio-pharmaceuticals).
- EU regulatory experience, including CTR.
- Prior people management experience.
- Collaboration with multiple stakeholders, including external CROs.
- Strong verbal and written communication skills.
- Ability to handle multiple competing tasks in a fast-growing environment.
- Self-directed, goal-oriented, resourceful, and organized with strong attention to detail.
- Lead preparation and maintenance of INDs, BLAs, and clinical trial applications (e.g., CTR) compliant with US, foreign regulatory requirements, and company standards.
- Serve as regulatory lead on assigned project teams, providing regulatory leadership, guidance, and oversight.
- Support global regulatory activities; remote/hybrid role with some travel to the New Providence, NJ office once a quarter or more as needed.
Job 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.
- Liaise between the company and global health authorities (including FDA).
- Prepare meeting requests and briefing documents; develop meeting strategies and ensure team readiness.
- Prepare regulatory development plans.
- Develop and maintain knowledge of US, EU, and ROW regulations.
- Coordinate and prepare responses to regulatory agency requests for information.
- Interface with CMC, nonclinical, and clinical personnel; communicate relevant new regulations/standards/policies.
- Assist in maintaining active INDs/CTAs/CTRs/BLAs (amendments and annual reports).
- Assist in developing and maintaining departmental processes, policies, SOPs, and related documents.
Who You Are (Qualifications):
- 15+ years’ biotech/pharma research experience, including 10+ years in Regulatory Affairs.
- Bachelor’s degree in a scientific discipline or equivalent (PhD/Master’s preferred).
- Experience in regulatory strategic support across all phases of drug development.
- Experience preparing, submitting, and supporting FDA review of INDs/BLAs/NDAs.
Preferred Skills/Experience:
- Oncology drug development experience (e.g., immuno-oncology, hematology, ADCs, bio-pharmaceuticals).
- EU regulatory experience, including CTR.
- Prior people management experience.
- Collaboration with multiple stakeholders, including external CROs.
- Strong verbal and written communication skills.
- Ability to handle multiple competing tasks in a fast-growing environment.
- Self-directed, goal-oriented, resourceful, and organized with strong attention to detail.