Associate Director, US Regulatory CMC — Strategy

Bayer AG; Whippany (NJ); On-site; USD 140,000 - 210,000; Full time

Benefits offered by this job

Health care

Vision

Dental

Retirement

PTO

Sick leave

Job summary

Bayer AG in Whippany, NJ is seeking an Associate Director, US Regulatory CMC to lead US CMC regulatory strategy for development and marketed products. This Local Hybrid role requires 2-3 days in the office weekly and close collaboration with FDA and cross-functional teams.

The successful candidate will plan and execute CMC submissions for INDs/NDAs, manage risk, and drive regulatory decisions across projects while ensuring compliance and high-quality communication in English.

Qualifications

• Bachelor’s degree in life science or related field.
• US FDA regulatory experience including CMC.
• In-depth knowledge of US regulatory environment and ICH guidance related to CMC.
• Ability to work collaboratively and influence without authority.
• Strong knowledge of the drug development process and FDA regulations with a focus on CMC.
• Experience with drug/device development processes.
• Project management skills with attention to detail and ability to multitask under time pressure.
• Ability to manage ambiguity and proactively address complex regulatory issues.
• Strong oral and written English communication skills.

Responsibilities

• Lead CMC regulatory strategy activities for US products in collaboration with US RA colleagues and FDA.
• Ensure US RA CMC activities align with commercial and R&D objectives and comply with US regulations.
• Develop CMC submission materials for INDs and NDAs; lead post-approval CMC changes submissions.
• Identify regulatory risks and develop mitigation plans.
• Organize and lead FDA meetings/interactions and act as primary FDA contact for CMC on projects.
• Manage virtual or cross-functional teams and align US RA activities.
• Participate in ad hoc projects to advance Regulatory Affairs activities.

Skills

US FDA regulatory experience

US regulatory environment knowledge

Collaborative ability

Drug development process knowledge

Project management

Ambiguity management

English communication

Negotiation skills

Education

Bachelor’s degree in life science or related field

Job description

Bayer AG in Whippany, NJ is seeking an Associate Director, US Regulatory CMC to lead US CMC regulatory strategy for development and marketed products. This Local Hybrid role requires 2-3 days in the office weekly and close collaboration with FDA and cross-functional teams.

The successful candidate will plan and execute CMC submissions for INDs/NDAs, manage risk, and drive regulatory decisions across projects while ensuring compliance and high-quality communication in English.