Senior Regulatory CMC Strategist — Cell Therapy Leader

Bayer (Schweiz) AG; Berkeley (CA); On-site; USD 219,000 - 328,000; Full time

Job summary

Bayer (Schweiz) AG is seeking a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell therapy programs and manage regulatory submissions across US and international authorities.

The role requires an advanced scientific degree, deep regulatory CMC experience in biologics or cell therapy, and strong leadership skills to mentor teams and coordinate with multiple departments. Up to 20% travel is expected.

Qualifications

• Advanced scientific degrees in biology, chemistry, pharmacology, or related field.
• Biotech/pharma regulatory CMC experience for biologics/cell therapy is required.
• Strong leadership and collaboration across global teams with diverse experts.

Responsibilities

• Represent Regulatory CMC and lead matrix teams for cell therapy programs.
• Develop and implement robust CMC strategies for cell and gene therapy.
• Lead CMC-related Health Authority interactions and prepare regulatory submissions.
• Coordinate with RA, QA, Clinical, Development, and Manufacturing teams to ensure compliant development.
• Identify and mitigate major regulatory risks and drive timely approvals.
• Monitor global regulations and communicate risks, opportunities, and recommendations to leadership.

Skills

Leadership

Communication

Regulatory knowledge

Stakeholder management

Travel ability

Education

Advanced scientific degree (PhD/MSc/PharmD)

Job description

Bayer (Schweiz) AG is seeking a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell therapy programs and manage regulatory submissions across US and international authorities.

The role requires an advanced scientific degree, deep regulatory CMC experience in biologics or cell therapy, and strong leadership skills to mentor teams and coordinate with multiple departments. Up to 20% travel is expected.