Regulatory CMC Associate Director (Hybrid, US)

Bayer; Whippany (NJ); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer is seeking an Associate Director, US Regulatory CMC in Whippany, NJ, to lead CMC regulatory strategies for its US portfolio. The role requires collaboration with FDA and internal teams, ensuring regulatory compliance and timely submissions.

Ideal candidates bring a bachelor’s in life sciences, U.S. regulatory experience, and strong communication skills; a graduate degree is preferred. Local hybrid work 2–3 days office, with a competitive salary and comprehensive benefits.

Qualifications

• Bachelor's degree in life science or related field.
• US FDA regulatory experience including CMC.
• Knowledge of US regulatory environment and ICH guidance related to CMC.
• Ability to work collaboratively and influence without authority.
• Strong communication and negotiation skills.

Responsibilities

• Lead US CMC regulatory strategy activities for assigned products with US RA and FDA.
• Ensure US RA CMC activities align with commercial and R&D objectives and comply with regulations.
• Develop CMC submission materials for INDs and NDAs; lead post-approval CMC changes.
• Identify regulatory risks and develop mitigation plans.
• Prepare for FDA meetings and serve as primary FDA contact for CMC.

Skills

Regulatory strategy

Cross-functional collaboration

Project management

Communication

Education

Bachelor’s degree in life science or related field

Graduate degree (PhD, PharmD, or MS) preferred

Job description

Bayer is seeking an Associate Director, US Regulatory CMC in Whippany, NJ, to lead CMC regulatory strategies for its US portfolio. The role requires collaboration with FDA and internal teams, ensuring regulatory compliance and timely submissions.

Ideal candidates bring a bachelor’s in life sciences, U.S. regulatory experience, and strong communication skills; a graduate degree is preferred. Local hybrid work 2–3 days office, with a competitive salary and comprehensive benefits.