Senior Regulatory CMC Strategist (Senior Director)

Bayer

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, you'll find it here.

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

More jobs at Bayer