Associate Director, US Regulatory CMC

Bayer AG; 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 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

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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.

Associate Director, US Regulatory CMC

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:

• 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.

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