Hybrid Associate Director, US Regulatory CMC

Socket.dev; Virginia (MN); 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 is seeking an Associate Director, US Regulatory CMC to lead CMC regulatory strategies for US products. The role requires coordinating with US RA and FDA, developing submission materials for INDs/NDAs, and guiding post-approval changes.

The position is a local hybrid role based in Whippany, NJ with 2–3 days in-office. Applicants should have a life science degree, US FDA regulatory experience with CMC, and strong English communication skills.

Qualifications

• Requires a Bachelor’s degree in life science or related field.
• US FDA regulatory experience including CMC.
• Knowledge of US regulatory environment and drug development processes (ICH guidance related to CMC).
• Ability to collaborate and influence without authority.
• Strong communication skills in English.

Responsibilities

• Lead CMC regulatory strategy activities for US products in collaboration with US RA colleagues and FDA.
• Ensure US RA CMC activities align with regulatory guidelines and project objectives; drive key CMC decisions.
• Develop CMC submission materials for INDs and NDAs; lead post-approval CMC changes submissions.
• Identify regulatory risks and develop mitigation/contingency plans.
• Organize and lead FDA meetings; act as primary FDA contact for CMC on projects.
• Manage cross-functional teams and ensure alignment of US RA activities.

Skills

English communication

Education

Bachelor’s degree in life science

Graduate degree preferred

Job description

Bayer is seeking an Associate Director, US Regulatory CMC to lead CMC regulatory strategies for US products. The role requires coordinating with US RA and FDA, developing submission materials for INDs/NDAs, and guiding post-approval changes.

The position is a local hybrid role based in Whippany, NJ with 2–3 days in-office. Applicants should have a life science degree, US FDA regulatory experience with CMC, and strong English communication skills.