Associate Director, US Regulatory CMC

Merck & Co.; Whippany (NJ); Hybrid; USD 140,000 - 210,000; Full time

Benefits offered by this job

Local Hybrid role

Job summary

Bayer is seeking an Associate Director, US Regulatory CMC in Whippany, NJ. You will lead CMC regulatory strategy for US products, coordinating with FDA and cross-functional teams to ensure compliance and timely submissions.

The role is a local hybrid with 2-3 days in the office. A Bachelor’s in life sciences and US FDA CMC experience are required, with a graduate degree preferred.

Qualifications

• US FDA regulatory experience including CMC.
• Knowledge of US drug development and ICH guidance for CMC.
• Ability to lead regulatory strategy and cross‑functional teams.

Responsibilities

• Lead CMC regulatory strategy activities for US products with FDA input.
• Develop CMC submission materials for INDs and NDAs and manage changes.
• Identify regulatory risks and drive mitigation plans.
• Prepare for FDA meetings and act as primary FDA contact for CMC.
• Coordinate virtual and cross-functional teams to align RA activities.

Skills

FDA regulatory

CMC knowledge

Regulatory strategy

Project management

English communication

Cross-functional leadership

Education

Bachelor’s degree in life science or related field

Graduate degree (PhD/ PharmD/ MS) preferred

Job description

Associate Director, US Regulatory CMC

At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where 'Health for all Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support the Bayer’s development and marketed product portfolios.

Please Note: This position is a Local Hybrid role reporting out of Whippany, NJ Corporate Headquarters. Candidates are expected to work from our office 2-3 days a week with some flexibility.

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director US Regulatory Affairs CMC, are:

• Responsible for leading the CMC regulatory strategy activities for assigned US products in close cooperation with respective US RA colleagues and FDA. Represents US Regulatory Affairs on assigned project teams;
• Ensures US RA CMC activities are in line with US commercial and R&D objectives, and in compliance with US regulatory guidelines and legal requirements for the assigned product portfolio and actively drives all key CMC regulatory decisions for assigned US projects;
• Develops CMC submission materials for INDs and NDAs and leads the submission activities for post-approval CMC changes;
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plans;
• Organizes and leads preparations for CMC related FDA meetings/interactions and acts as the primary FDA contact for all CMC interactions on assigned projects;
• Manage virtual and/or cross functional, multidisciplinary teams; and drives alignment of US RA activities (internal and outsourced activities). Represents US RA on project teams;
• Participates in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs activities;

WHO YOU ARE

Bayer seeks an incumbent who possesses the following:

Required Qualifications

• A Bachelor’s degree in life science or related field is required;
• US FDA regulatory experience which includes CMC experience, required;
• In-depth knowledge of the US regulatory environment and the process of drug development, including aspects of pharmaceutical development (e.g. formulations, analytics etc.) as well as ICH guidance related to CMC;
• Ability to work collaboratively and influence without authority;
• Strong knowledge of the drug development process, FDA regulations policies with a focus on CMC;
• Strong knowledge of the drug/device development process;
• Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure;
• Ability to manage significant ambiguity and effectively and proactively steer and solve diverse and complex business and regulatory issues;
• Strong ability to communicate in both oral and written English, with proven persuasive and assertive negotiating skills.

Preferred Qualifications :

• Graduate degree (PhD, PharmD, or M.S.) preferred;
• At least 4 years of pharmaceutical industry experience, preferred.

Employees can expect to be paid a salary of between $139,800 to $209,700. Additional compensation may include a bonus or commission (if relevant). Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.. This salary range is merely an estimate and may vary based on an applicant’s location, market data/ranges, an applicant’s skills and prior relevant experience, certain degrees and certifications, and other relevant factors.

This posting will be available for application until at least: October 2, 2026.

#LI-US

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Equal Opportunity Employer Statement: Notice for U.S. Visitors: All information on this site is subject to compliance with local rule and regulations as they may vary from time to time and across different geographies, including, without limitation, U.S. Executive Orders. Bayer is an E-Verify Employer.

Location:

United States : New Jersey : Whippany

Division:

Pharmaceuticals

Reference Code:

887351

Contact Us

Email: [e-mail]