Senior Regulatory CMC Strategist (Senior Director)

At Bayer we believe work should matter. Every day our teams push toward a future where Health for all Hunger for none is within reach and every role from the lab to the field to the boardroom helps us get there. We give people the ownership to shape outcomes the support to grow through new skills and experiences and a global community where different perspectives are valued. If you want your work to count and the room to become your best youll find it here.

Senior Regulatory CMC Strategist (Senior Director)

The Senior Regulatory CMC Strategist (Senior Director) leads innovative global CMC strategies for product development and approval and providing regulatory CMC leadership and guidance to CMC teams developing cell and gene therapy products. The position also serves as the Regulatory CMC Leader for advanced cell therapy products; leads a team of Regulatory CMC experts in a matrix setting. The position also builds and maintains relationships with internal stakeholders as well as external consultants/contractors as necessary to support regulatory activities and provide leadership and guidance to the organization on global CMC matters. Experience and knowledge of global regulations for the development of cell therapy products is required and any experience in the neurology and/or ophthalmology therapeutic areas is desired.

This position will be ideally based out of Berkely CA or someone who can commit to traveling to Berkely CA frequently. A residence based option may be considered for the selected candidate.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role Senior Regulatory CMC Strategist (Senior Director) are to:

• 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 robust innovative CMC strategies for cell and gene therapy programs providing guidance 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 closely 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 major routine and complex regulatory risks deficiencies change controls and strategic issues. Independently manage and prioritize multiple 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 strong relationships with agencies subsidiaries contractors partners and industry organizations while mentoring colleagues and shaping regulatory strategy policy and organizational change;
• Demonstrate credibly embody and role model VACC leadership being a(n):

• Visionary that guides teams in defining the outcomes to deliver on the mission;
• Architect that shapes a value creating system to unleash the passion and energy of our people;
• Catalyst that removes roadblocks to facilitate connections and collaboration;
• Coach that helps teams learn and build the capabilities needed to create value for the customer and stakeholders.

Key Work Relations: Internal/External Customers

This position has a significant scope of interaction both internally within Bayer and externally with health authorities professional organizations and industry partners.

Internal:

• Works with other Regulatory CMC Strategists other RA functions (Global Regulatory Strategists CMC experts Medical Device experts Regulatory Policy & Science Labeling RA Regions);
• R&D functions (Clin Dev & Ops) Medical Devices & Combination Products; CMC & Technology Radiology;
• Works with Product Supply Research & Development Portfolio Management Development Commercial Market Access BD&L and other functions as relevant;
• Works within Bayer and with its CGT subsidiaries.

External:

• Interacts with Health Authorities globally presenting validating and negotiating development plans as applicable;
• Interacts with co-development partners representing Bayer RA in joint project teams;
• Participates in external collaborations with trade organizations (BIO ARM etc) and funding entities for special projects to progress the CGT programs.

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications:

• Advanced scientific degree (e.g. PhD MSc PharmD);
• Biotech or pharmaceutical industry experience including relevant regulatory CMC experience with development of biologics (cell therapy required gene therapy a plus) and US and global submissions;
• The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics deep experience in product development and understanding of US international regulations and ICH guidelines related to biologics and cell therapy development;
• Extensive experience in preparing quality sections of regulatory filings including global Health Authority briefing documents IND/CTA/IMPDs and BLA/MAAs following eCTD format. Proven leadership in major marketing authorization application (such as an NDA BLA or MAA);
• Lead regulatory CMC discussions with regulatory authorities in US and ex-US;
• Experience in the development and implementation of complex regulatory strategies with a proven track record of significant regulatory accomplishments;
• Ability to understand technical aspects of manufacturing and quality control assays and describe them in regulatory submissions and understand regulatory impact;
• Strong interpersonal skills and the ability to collaborate effectively with various technical area experts including process development manufacturing Quality Assurance Quality Control non-clinical development clinical development and clinical operations;
• Excellent communication skills verbal and written including fluency in English attention to detail; digital savvy including appropriate use of AI and understanding data modeling approaches;
• Ability to travel within US/Canada (and some additional limited EU travel possible) up to 20% is required;
• Excellent leadership and negotiation skills and demonstrated experience modeling positive communications and collaboration interpersonal and relationship-building skills are a must;
• Must be able to work within a global team framework and a multi-cultural environment;
• Professionalism and organizational savvy are essential as the job holder works directly with different hierarchical levels within Bayer and CGT subsidiaries;
• Proven ability to establish relationships between Bayer and CGT subsidiaries as well as individual departments;
• Ability to process large amounts of technical information efficiently and provide sound judgments to manage complex problems effectively.

Preferred:

• Advanced scientific degree (e.g. PhD MSc PharmD) in Biology Chemistry Pharmacology or related discipline preferred;
• 15 years biotech or pharmaceutical industry experience including at least 10 years of relevant regulatory CMC experience with development of biologics (cell therapy required gene therapy a plus) and US and global submissions;
• Experience with combination products and device filing also preferred.

Employees can expect to be paid a salary of between $218800 to $328300. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care vision dental retirement PTO sick leave etc. This salary range is merely an estimate and may vary based on an applicants location market data/ranges an applicants skills and prior relevant experience certain degrees and certifications and other relevant factors.

This posting will be available for application until at least: 11/2/2026.

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