CMC Senior Manager

4 weeks ago


New Brunswick, United States R&D Partners Full time

R&D Partners is seeking to hire a CMC Senior Manager in New Brunswick, NJ.

Your main responsibilities as a CMC Senior Manager:

Participate in the development of the CMC regulatory strategy for post-approval small molecule product submissions, including global supplements/variations and responses to health authority queries.

Prepare and review CMC submission documents, registration dossiers, and responses to health authorities through collaborations with relevant line functions and with minimal supervision.

May be responsible for the global regulatory evaluation of CMC change controls with supervision.

Work with CMC cross-functional teams and Regulatory Affairs teams.

Develop and maintain knowledge of regulatory environment, regulations and procedures..

What we are looking for in a CMC Senior Manager:

Experience with CMC regulatory documents (global registrations, including NDAs, MAAs and others, responses and supplements/variations)

Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations

Experience in post-approval requirements

Experience in developing CMC regulatory strategy

Experience in project management.

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

Medical insurance PPO, HMO & HSA

Dental & Vision insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Expense reimbursement

Online timecard approval


R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.




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