Global Regulatory CMC Director, Cell Therapy Strategy

Bayer

Whippany (NJ)

On-site

USD 219,000 - 328,000

Full time

5 days ago

Be an early applicant

A complete application in a minute

Tailored resume and cover letter, ready to send.

Get past ATS filters

Job summary

Bayer seeks a Senior Regulatory CMC Strategist to lead global CMC strategies for cell therapy products and provide regulatory leadership to cross-functional teams. This role reports into senior management and requires deep knowledge of US and international regulations, plus the ability to interact with health authorities and partners worldwide.

Based in the Berkeley area, with frequent travel to US sites and potential residence-based options, this position emphasizes strategic thinking,

Qualifications

Advanced scientific degree with regulatory CMC experience in biotech/pharma.
Experience with US and global submissions for biologics and cell therapy.
Strong regulatory CMC leadership across cross-functional teams.
Willingness and ability to travel up to 20% in US/Canada.

Responsibilities

Represent Regulatory CMC and lead matrix teams for cell therapy programs.
Develop and implement robust CMC strategies for regulatory submissions.
Lead health authority interactions, including briefing documents and responses.
Collaborate with RD, Quality, Regulatory Strategy and other teams.
Identify regulatory risks and manage multiple complex projects to deadlines.
Monitor global regulations and advise senior management on risks and opportunities.
Build relationships with agencies, contractors, and industry groups, mentoring staff.
Demonstrate VACC leadership: visionary, architect, catalyst, coach.