Senior Regulatory CMC Strategist (Senior Director)
Bayer
Summary
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.
Job description
Your Tasks and 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 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: Visionary, Architect, Catalyst, Coach
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
- 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 required with 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 Qualifications
- 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
Requirements
- 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
- 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 required with 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
Benefits
- Health care
- Vision
- Dental
- Retirement
- PTO
- Sick leave
Company overview
Bayer AG is a global life science company with core competencies in healthcare and agriculture, operating as one of the world's leading pharmaceutical corporations. Founded in 1863 and headquartered in Leverkusen, Germany, Bayer operates through three primary divisions: Pharmaceuticals, Consumer Health, and Crop Science. The company's pharmaceutical segment focuses on prescription products for cardiology, women's healthcare, oncology, hematology, and ophthalmology, with blockbuster drugs including Xarelto, Eylea, and Nubeqa. Bayer's Consumer Health division markets well-known over-the-counter brands such as Aspirin, Aleve, Claritin, and Bepanthen. The Crop Science division, strengthened by the acquisition of Monsanto, provides seeds, crop protection products, and digital farming solutions. With approximately 92,815 employees worldwide and operations in 80 countries, Bayer is committed to its mission of "Health for all, Hunger for none," driving innovation in medical treatments, agricultural productivity, and sustainable development. The company maintains a strong research and development pipeline, investing heavily in areas like precision medicine, artificial intelligence applications in healthcare, and sustainable agricultural technologies.