Global CMC Strategy Lead – Cell & Gene Therapy

Bayer; Tulsa (OK); On-site; USD 219,000 - 328,000; Full time

Benefits offered by this job

Health care

Vision and dental

Retirement plan

Paid time off

Job summary

Bayer seeks a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell and gene therapy. The role directs a matrix of regulatory experts, builds relationships with agencies, and guides teams through US and international submissions.

The position is based in Berkeley, CA, with travel up to 20% and a potential residence-based option. Advanced degrees and extensive regulatory CMC experience are required.

Qualifications

• Advanced scientific degree and regulatory CMC experience in biotech/pharma.
• Experience with global/US submissions and eCTD format.
• Leadership in major regulatory filings and cross-functional collaboration.

Responsibilities

• Represent Regulatory CMC and lead matrix teams for cell therapy programs.
• Develop and implement robust CMC strategies for cell and gene therapy.
• Lead Health Authority interactions including briefing documents and responses.
• Collaborate with RA, QA, Clinical, and Development teams to enable compliant submissions.
• Identify/regulatory risks and manage multiple complex projects to meet deadlines.
• Monitor global regulations and communicate risks and opportunities to leadership.
• Build relationships with agencies, subsidiaries, contractors, and industry groups.
• Demonstrate VACC leadership as Visionary, Architect, Catalyst, and Coach.

Skills

Regulatory CMC expertise

Leadership

English fluency

Education

Advanced scientific degree (PhD, MSc, PharmD)

Job description

Bayer seeks a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell and gene therapy. The role directs a matrix of regulatory experts, builds relationships with agencies, and guides teams through US and international submissions.

The position is based in Berkeley, CA, with travel up to 20% and a potential residence-based option. Advanced degrees and extensive regulatory CMC experience are required.