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.

The Senior Regulatory CMC Strategist (Senior Director) leads innovative global CMC strategies for product development and approval and provides regulatory CMC leadership and guidance to CMC teams developing cell and gene therapy products.

Key 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.

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.

Preferred Qualifications:

• 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.

Salary Range: $218,800 to $328,300

Benefits: Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.