Senior Director, Global Regulatory CMC — Cell Therapy

Bayer; Berkeley (CA); In loco; USD 219.000 - 328.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health care

Retirement plan

Paid time off

Descrizione del lavoro

Bayer seeks a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell and gene therapy programs and to guide regulatory submissions. You will manage a matrix team and interact with health authorities to ensure compliant, timely filings.

Based in Berkeley or able to travel to Berkeley, CA frequently, you will partner with RA, QA, Clinical, and Development functions to advance biologics programs and build a robust regulatory strategy across regions.

Competenze

• Advanced regulatory CMC expertise including biologics and cell therapy.
• Experience with US/global submissions and eCTD format.
• Proven leadership in major regulatory filings (NDA/BLA/MAA).
• Strong regulatory strategy and health authority interaction skills.
• Ability to travel up to 20% within US/Canada.

Mansioni

• 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 interactions with Health Authorities; manage submissions.
• Collaborate with DPM, Analytical Development, QA, and Clinical teams.
• Identify regulatory risks and drive issue resolution to meet deadlines.

Conoscenze

Regulatory CMC leadership

Global regulatory strategy

Team leadership

Cross-functional collaboration

English fluency

Formazione

Advanced scientific degree (PhD/MSc/PharmD)

Descrizione del lavoro

Bayer seeks a Senior Regulatory CMC Strategist (Senior Director) to lead global CMC strategies for cell and gene therapy programs and to guide regulatory submissions. You will manage a matrix team and interact with health authorities to ensure compliant, timely filings.

Based in Berkeley or able to travel to Berkeley, CA frequently, you will partner with RA, QA, Clinical, and Development functions to advance biologics programs and build a robust regulatory strategy across regions.