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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.

Global Regulatory CMC Manager

Job Description

  • Location: Summit, NJ
  • Type: Contract
  • Job #68010

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

 

Work Location:

Summit, NJ
 

Required Skills:

  • BS/BA degree in Scientific Discipline (Masters or higher preferred) with
  • 5-7 years in the pharmaceutical industry, with CMC regulatory experience
  • Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents)
  • Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations
  • Experience in drug development processes and 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

 

Responsibilities:

  • Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions
  • These submissions include health authority briefing packages, IND/CTA, BLA/NDA and MAA regulatory filings
  • Prepare and review CMC submission documents, registration dossiers, health authority briefing packages and responses to health authorities through collaborations with relevant line functions and with minimal supervision
  • Responsible for the global regulatory evaluation of CMC change controls with supervision
  • Responsible for the management of CMC activities related to developmental or commercial compounds, with supervision
  • Represent Regulatory CMC on cross-functional development/commercial teams and Regulatory Affairs teams
  • Participate in global regulatory interactions with health authorities, with supervision
  • Facilitate document review meetings and discussions
  • Develop and maintain knowledge of regulatory environment, regulations and procedures
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