Senior Director, Regulatory & Scientific Affairs

We are seeking an accomplished Senior Director, Regulatory Strategy & Affairs (RSA) with deep expertise in CMC, non‑clinical development, cell and gene therapy (CGT) regulatory strategy, and medical device/combination product requirements.

This role will serve as a senior subject‑matter expert responsible for shaping global regulatory strategies for advanced modalities and ensuring programs meet evolving regulatory expectations in CMC, non‑clinical, and device pathways.

What You'll Do:

CMC & Cell and Gene Therapy (Ideally)


* Lead CMC regulatory strategy for biologics and cell and gene therapy products, including viral vector platforms, cell‑based products, and other novel modalities.


* Guide CMC comparability, potency strategy, analytical characterization, process development, and control‑strategy expectations specific to CGT.


* Develop global regulatory strategies addressing ATMP requirements, RMAT designations, and CGT‑specific CMC submissions.


* Advise cross‑functional teams on evolving CGT regulatory frameworks (e.g., FDA, EMA, MHRA) and associated expectations for manufacturing, testing, and lifecycle changes.

Non‑Clinical Strategy (Critical Area)


* Provide expert regulatory guidance on non‑clinical development, including:



* Toxicology and pharmacology program design


* Biodistribution, shedding, and persistence studies for CGTs


* Immunogenicity and tumorigenicity assessments

Ensure non‑clinical strategies align with global agency requirements for first‑in‑human, early‑phase, and pivotal development.
Device / Combination Products


* Lead regulatory strategy for medical device and combination product components, including EU MDR, FDA device pathways, and device‑specific documentation.

Cross‑Functional Leadership & Global Agency Interface


* Represent programs in global health authority interactions for CMC, non‑clinical, and device topics.


* Lead preparation of IND/CTA submissions, IMPDs, BLA/NDA/MAA content, and briefing packages.


* Mentor team members and help build internal regulatory capability in advanced modalities and specialized CMC/non‑clinical domains.

Lead global CMC regulatory strategy for assigned programs, guiding early development through registration and lifecycle management.

Experience in Cell and Gene Therapy would be:


* Provide expert regulatory input on non‑clinical study design, strategy, and data interpretation to ensure alignment with global health authority expectations.


* Serve as regulatory lead for medical device and combination product strategy, including MDR, FDA device pathways, and device‑related submission content.


* Develop, author, and review high‑quality global regulatory documents, including IND/CTA submissions, IMPD, BLA/NDA/MAA components, and agency briefing packages.


* Lead interactions with global health authorities (FDA, EMA, MHRA, etc.) for CMC, non‑clinical, and device t...