Director, Regulatory Affairs

Director, Regulatory Affairs (Oncology/Hematology)

Responsibilities
- Develop and implement US and global regulatory strategies for assigned projects.
- Lead/oversee preparation, submission, approval, and maintenance of regulatory applications (e.g., IND/CTA, NDA/MAA, designation requests, pediatric study plans); author documents; draft responses to agency queries; coordinate submissions with regulatory operations.
- Manage regulatory agency communications/interactions; prepare briefing materials; coordinate rehearsals and minutes.
- Advise cross-functional development teams on regulatory requirements and approval pathways, including potential expedited pathways.
- Advise leadership on regulatory risks, considerations, and strategies.
- Ensure compliance of activities and submissions with applicable laws, regulations, and guidance.
- Provide strategic/technical regulatory input to key product development documents.
- Conduct regulatory research/intelligence to monitor the evolving regulatory landscape.

Qualifications / Skills
- 10+ years pharma/biotech industry experience; 5+ years regulatory experience.
- PharmD/MS preferred, or Bachelor’s degree in life science.
- Experience supporting NDAs and post-approval products/drug labeling (preferred).
- Experience leading IND/CTA submissions for clinical trials.
- Excellent written and verbal communication; strong organization and interpersonal skills; attention to detail.
- Solid knowledge of drug development; experience planning/managing IND/CTA submissions.
- Experience working with FDA and/or other agencies.
- Strong understanding of US and EU regulatory landscape.
- Hematology/Oncology or orphan-drug experience preferred.
- Ability to think critically and analyze scientific information; influence/negotiation across levels.

Compensation/Benefits (explicit)
- Base range: $226,495–$258,817/year.
- Benefits include 20 days PTO to start, 401K with employer contributions, stock options, bonus, and paid paternity/maternity leave.