Associate Director, US Regulatory CMC — Hybrid

Bayer CropScience Limited; New Hanover Township (NJ); On-site; USD 140,000 - 210,000; Full time

Job summary

Bayer is seeking an Associate Director, US Regulatory CMC in Whippany, NJ for a local hybrid role. You will lead CMC regulatory strategy for US products, coordinate with RA colleagues and the FDA, and drive submission activities across INDs and NDAs.

The role requires a strong US regulatory background, CMC expertise, and the ability to manage cross‑functional teams in a fast‑paced environment. Collaboration and communication in English are essential.

Qualifications

• Bachelor’s degree in life science or related field.
• Regulatory experience with US FDA, including CMC.
• Knowledge of US regulatory environment and drug development process.

Responsibilities

• Lead CMC regulatory strategy for US products with RA colleagues and FDA.
• Ensure CMC activities align with regulatory and development objectives.
• Develop CMC submission materials for INDs/NDAs and lead post‑approval changes.
• Identify regulatory risks and develop mitigation plans.
• Organize/lead FDA meetings and act as primary FDA contact for CMC.
• Manage cross‑functional teams and drive alignment of US RA activities.

Skills

US FDA regulatory

CMC experience

Regulatory strategy

Project management

English communication

Collaborative work

Education

Bachelor’s degree in life science or related field

Graduate degree (PhD/PharmD/MS) preferred

Job description

Bayer is seeking an Associate Director, US Regulatory CMC in Whippany, NJ for a local hybrid role. You will lead CMC regulatory strategy for US products, coordinate with RA colleagues and the FDA, and drive submission activities across INDs and NDAs.

The role requires a strong US regulatory background, CMC expertise, and the ability to manage cross‑functional teams in a fast‑paced environment. Collaboration and communication in English are essential.