Associate Director, Regulatory

Role Summary

Associate Director, Regulatory. This role serves as the Regulatory Lead for the pivotal program leading to BLA, developing and executing regulatory strategies to support the development and commercialization of cell therapy products. The position involves working with cross-functional teams, regulatory agencies, and external partners to ensure compliance and successful product registration. Remote option or based at Philadelphia, PA headquarters.

Responsibilities

• Regulatory Strategy Development: Manage all regulatory aspects of the lead program through pivotal clinical studies and BLA/MAA approval, including preparation of clinical trial applications, amendments, correspondence, requests for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies (FDA, Health Canada, EMA, MHRA, and others).
• Collaborate with cross-functional teams to develop and implement competitive regulatory strategies that expedite development and maximize success probability for cell therapy product development.
• Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly; assess regulatory risks and propose mitigation plans.
• Regulatory Submissions and Compliance: Prepare and oversee submissions (INDs, CTAs, BLAs/MAAs, etc.) to regulatory agencies; ensure quality and timeliness of submissions; ensure program documentation complies with current regulations and guidelines.
• Regulatory Interactions: Represent the company in interactions with regulatory agencies; prepare meeting requests, briefing documents, coordinate teams for meetings, and respond to information requests; build and maintain positive relationships with authorities to facilitate approvals.

Qualifications

• Bachelor's degree in life sciences or related field required (advanced degree preferred).
• Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred).
• Strong understanding of the drug development process from pre-clinical to commercialization; prior BLA experience required.
• Experience reviewing and writing regulatory submission documents for global regulatory filings (IND, CTAs, BLAs/MAAs) and health authority interactions.
• Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions.
• Excellent communication, negotiation, and leadership skills; strong team orientation and commitment to self-development.