Senior Regulatory CMC Strategist (Senior Director)

Bayer•Berkeley, CA

About The Position

The Senior Regulatory CMC Strategist (Senior Director) leads global CMC strategies for product development and approval and provides regulatory CMC leadership and guidance to teams developing cell and gene therapy products. The role serves as the Regulatory CMC Leader for advanced cell therapy products and leads Regulatory CMC experts in a matrix setting. It builds relationships with internal stakeholders and external consultants and contractors to support regulatory activities and provide guidance on global CMC matters. Experience with global regulations for cell therapy development is required; experience in neurology and/or ophthalmology is desired. The position is ideally based in Berkeley, California, or for a candidate able to travel there frequently; a residence-based option may be considered. The role has broad internal and external interactions, including with Bayer regulatory, research and development, product supply, portfolio, development, commercial, market access, business development, and CGT subsidiary teams. Externally, it interacts with global health authorities, co-development partners, trade organizations, and funding entities. Travel within the US and Canada, with some limited EU travel possible, is required up to 20%. The expected salary range is $218,800 to $328,300. Additional compensation may include a bonus or commission, if relevant. Benefits include health care, vision, dental, retirement, PTO, and sick leave. The posting is available for application until at least 11/2/2026.

Requirements

Advanced scientific degree, such as a PhD, MSc, or PharmD.
Biotechnology or pharmaceutical industry experience, including relevant regulatory CMC experience developing biologics; cell therapy experience is required, and gene therapy experience is a plus.
Experience with US and global submissions and understanding of US and international regulations and ICH guidelines related to biologics and cell therapy development.
Extensive experience preparing quality sections of regulatory filings, including global Health Authority briefing documents, IND/CTA/IMPDs, and BLA/MAAs in eCTD format.
Proven leadership in a major marketing authorization application, such as an NDA, BLA, or MAA.
Experience leading regulatory CMC discussions with US and ex-US regulatory authorities.
Experience developing and implementing complex regulatory strategies, with a proven record of significant regulatory accomplishments.
Ability to understand technical aspects of manufacturing and quality control assays, describe them in regulatory submissions, and understand their regulatory impact.
Ability to collaborate effectively with technical experts in process development, manufacturing, Quality Assurance, Quality Control, nonclinical development, clinical development, and clinical operations.
Excellent verbal and written communication skills and fluency in English, with attention to detail.
Digital savvy, including appropriate use of AI and understanding of data modeling approaches.
Ability to travel within the US and Canada, with some additional limited EU travel possible, up to 20%.
Excellent leadership and negotiation skills, with demonstrated positive communication, collaboration, interpersonal, and relationship-building skills.
Ability to work in a global team framework and multicultural environment.
Professionalism and organizational savvy when working with different hierarchical levels within Bayer and CGT subsidiaries.
Ability to establish relationships between Bayer and CGT subsidiaries and individual departments.
Ability to efficiently process large amounts of technical information and use sound judgment to manage complex problems.

Nice To Haves

Advanced scientific degree in Biology, Chemistry, Pharmacology, or a related discipline.
15 years of biotechnology or pharmaceutical industry experience, including at least 10 years of relevant regulatory CMC experience developing biologics and preparing US and global submissions.
Gene therapy experience.
Experience with combination products and device filings.
Experience in neurology and/or ophthalmology therapeutic areas.

Responsibilities

Represent Regulatory CMC and lead matrix teams for cell therapy programs, including participation in development and global regulatory teams across therapeutic areas.
Develop and implement CMC strategies for cell and gene therapy programs and guide teams on regulatory requirements for clinical trial and marketing applications.
Lead CMC-related Health Authority interactions, including briefing documents, responses to questions, submissions, and resolution of regulatory issues.
Partner with CMC, Analytical Development, Quality, Nonclinical, Clinical, Regulatory Strategy, and Quality Assurance teams to support compliant development and submissions.
Identify, assess, escalate, and propose solutions for regulatory risks, deficiencies, change controls, and strategic issues.
Manage and prioritize multiple complex projects independently to meet submission deadlines and secure timely approvals.
Monitor global regulations, guidance, and agency activities; anticipate regulatory shifts and communicate risks, opportunities, and recommendations to senior and executive management.
Build relationships with agencies, subsidiaries, contractors, partners, and industry organizations.
Mentor colleagues and shape regulatory strategy, policy, and organizational change.
Model VACC leadership by guiding teams, shaping systems, removing roadblocks, facilitating collaboration, and building team capabilities.
Present, validate, and negotiate development plans with health authorities globally, as applicable.
Represent Bayer Regulatory Affairs in joint project teams with co-development partners and participate in external collaborations with trade organizations and funding entities.