Senior Regulatory CMC Strategist (Senior Director)

Bayer•Tulsa, OK

6h•$218,800 - $328,300

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 Regulatory CMC Leader for advanced cell therapy products and leads a matrix team of Regulatory CMC experts. It builds relationships with internal stakeholders and external consultants and contractors to support regulatory activities and provide organizational leadership on global CMC matters. Cell therapy regulatory experience is required; gene therapy experience is a plus. Experience in neurology and/or ophthalmology is desired. The position is ideally based in Berkeley, California, or suited to someone who can travel to Berkeley frequently; a residence-based option may be considered. The role has significant interaction with Bayer teams, health authorities, professional organizations, industry partners, co-development partners, subsidiaries, and funding entities. Travel within the United States and Canada, with possible limited European travel, is required up to 20%.

Requirements

Advanced scientific degree, such as a PhD, MSc, or PharmD.
Biotechnology or pharmaceutical industry experience, including relevant Regulatory CMC experience in biologics development; cell therapy experience is required.
Experience with US and global regulatory submissions.
Strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company, with biologics expertise 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, INDs, CTAs, IMPDs, and BLAs/MAAs following eCTD format.
Proven leadership in a major marketing authorization application, such as an NDA, BLA, or MAA.
Experience leading Regulatory CMC discussions with regulatory authorities in the US and outside the US.
Experience developing and implementing complex regulatory strategies with a 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 process development, manufacturing, Quality Assurance, Quality Control, nonclinical development, clinical development, and clinical operations experts.
Excellent verbal and written communication skills, fluency in English, and attention to detail; digital savvy, including appropriate use of AI and understanding data modeling approaches.
Ability to travel within the US and Canada, with possible limited EU travel, up to 20%.
Excellent leadership and negotiation skills, with demonstrated positive communication, collaboration, interpersonal, and relationship-building skills.
Ability to work within a global team framework and multicultural environment.
Professionalism and organizational savvy when working across hierarchical levels within Bayer and CGT subsidiaries.
Proven ability to establish relationships between Bayer and CGT subsidiaries and their departments.
Ability to process large amounts of technical information efficiently and exercise sound judgment in managing complex problems.

Nice To Haves

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

Responsibilities

Represent Regulatory CMC and lead matrix teams for cell therapy programs, participating 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; independently manage and prioritize complex projects 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 coaching teams to build capabilities.
Represent Bayer in interactions with global health authorities, co-development partners, trade organizations, and funding entities as applicable.
Work with internal Regulatory Affairs, R&D, Medical Devices and Combination Products, CMC and Technology, Radiology, Product Supply, Portfolio Management, Development, Commercial, Market Access, BD&L, and CGT subsidiaries.