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About TSR:

TSR is a relationship-based, customer-focused IT and technical services staffing company.

For over 40 years TSR, Inc. and its wholly owned subsidiary, TSR Consulting Services, have prospered in the Information Technology staffing business, earning the respect of companies both large and small with well refined candidate screening, timely placement, and a real understanding of the right skill sets required by our clients.

Mission & Vision

We do not believe in building a vision around the company but building a company around our vision, which is simply;

Every employee’s voice matters, their effort is appreciated, and their talent is rewarded.

We challenge each employee daily, to raise the bar on how we treat our consultants and candidates. For far too long in this industry, candidates have been ghosted, lied to, or placed at a client and then forgotten about. Each day our staff works tirelessly at qualifying and placing, top talent with our clients, in a compassionate and caring manner.

Not every candidate is a match for the job, but every candidate and consultant will be treated with respect and professionalism.

CMC Senior Manager

Job Description

  • Location: New Brunswick, New Jersey
  • Type: Contract
  • Job #79163

Our client, a leading pharmaceutical company, is hiring a CMC Senior Manager on a contract basis.

Job ID #: 79163

Work Location:
New Brunswick, NJ


  • BS/BA degree in Scientific Discipline (master’s preferred) with 5 years in the pharmaceutical industry, preferably with 3 years CMC regulatory experience.
  • 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.
  • Have a solution-oriented approach to problem solving.
  • Ability to plan/prioritize work of group members and guide/develop others.
  • Ability to work on complex projects and within cross-functional teams with supervision.
  • Excellent communication skills, both written and oral.
  • Excellent computer skills.


  • 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.
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