10 regulatory CMC experts

Experience: Director Reg CMC Strategy · Pfizer

Director Reg CMC Strategy at Pfizer since 2023, a role the profile says is accountable for regulatory CMC strategy, technical direction and all aspects of regulatory submissions for projects within the Pfizer Hospital Category Anti-Infectives portfolio. The profile also lists Regulatory Senior Manager, CMC at Pfizer (2019–2023).

Experience: Regulatory Affairs Director CMC · Ascendis Pharma

Regulatory Affairs Director CMC at Ascendis Pharma since 2019, a role the profile says included compilation of the CMC part of a US BLA and EU MAA for a biologic drug. The profile also lists RA CMC Specialist at Novo Nordisk (2014–2019) and Submission manager at Novo Nordisk (2013–2014).

Experience: Director Regulatory Affairs, CMC · Biogen

Director Regulatory Affairs, CMC at Biogen since 2021 and Director, Regulatory Affairs CMC at Alkermes from 2017 to 2021. The profile describes experience in global regulatory CMC strategy for development across small molecules and biologics, including serving as Reg CMC small molecule development team lead from pre-IND to NDA.

Experience: Director Regulatory Affairs CMC · Kailera Therapeutics

Director Regulatory Affairs CMC at Kailera Therapeutics since 2026. The profile also lists Director, Regulatory Affairs CMC at Dompé (2025–2026) and at Mural Oncology (2023–2024), and describes 14+ years in RA CMC supporting small molecules, biologics and combination products in pre- and post-approval work, including INDs, NDAs, BLAs and MAAs.

Experience: Senior Director, CMC Regulatory Affairs · Enzyvant

Former Senior Director, CMC Regulatory Affairs at Enzyvant (2021–2023) and Director, CMC Regulatory Affairs at Enzyvant (2018–2021). The profile lists Senior Director, Regulatory Affairs at Sumitomo Pharma America, Inc. since 2023, a role that includes serving as regulatory lead for RETHYMIC and leading agency interactions, including the addition of a new manufacturing facility.

Experience: Executive Director, Regulatory CMC · Xenon Pharmaceuticals Inc.

Executive Director, Regulatory CMC at Xenon Pharmaceuticals Inc. since 2026. The profile also lists Senior Director, Regulatory Affairs CMC (2024–2026) and Director, Regulatory Affairs CMC (2022–2024) at Xenon, and describes 10+ years setting global CMC regulatory strategies for small molecule and antisense oligonucleotide drugs at all stages of development.

Experience: Director- Global Regulatory Affairs CMC Biologics · Merck

Director- Global Regulatory Affairs CMC Biologics at Merck since 2022 and Director of Regulatory Affairs-CMC at Rocket Pharmaceuticals in 2022. The profile also lists Associate Director, Global Regulatory Affairs-CMC at Merck (2018–2022) and describes 10+ years of experience in biologics development as a global CMC regulatory affairs professional.

Experience: Director, CMC Regulatory · Ionis Pharmaceuticals, Inc.

Director, CMC Regulatory at Ionis Pharmaceuticals, Inc. since 2024. The profile describes more than 18 years of experience managing and delivering global CMC regulatory submissions and developing CMC regulatory strategy for investigational and commercial products, and it also lists a Director role at Pfizer (2019–2024).

Experience: Senior Director, Global Regulatory Affairs CMC · BioNTech SE

Senior Director, Global Regulatory Affairs CMC at BioNTech SE since 2025. The profile also lists Senior Director, Global Regulatory Science CMC at Moderna (2024–2025) and Director, Regulatory Affairs Vaccines CMC at Takeda (2021–2024), and describes 16+ years of experience in CMC and regulatory CMC within the industry and the FDA, spanning small molecules, vaccines and ATMPs.

Experience: Associate Director CMC Regulatory Affairs · Astellas Pharma

Associate Director CMC Regulatory Affairs at Astellas Pharma since 2021, a role the profile describes as Global Scientific Lead for CMC-RA, responsible for global CMC strategy for major products in development and on the market, including managing QOS and M3 preparation. The profile also lists Manager Regulatory Affairs Team Lead CMC at Teva Pharmaceuticals (2018–2020).