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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.

Regulatory CMC

Job Description

  • Location: San Diego, CA
  • Type: Contract
  • Job #76397

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

Work Location

San Diego, CA

Regulatory CMC Contractor

The contractor will assist the Regulatory-CMC Cell Therapy team with projects to support department goals and objectives.

Job Responsibilities require the following skills: Attention to detail, excellent organizational skills, good verbal and written communication skills are required.

Ability to work independently on routine assignments with regular check-ins and to work cooperatively with senior staff providing key assistance on complex assignments. Computer experience must include familiarity with Word, Excel and PowerPoint

Support Regulatory CMC Cell Therapy group in the preparation of submissions. These submissions include briefing books, IND, CTA (IMPD), BLA, MAA applications.


Must have 5+ years of pharmaceutical industry experience in manufacturing, pharmaceutical development or QA, with a minimum of 1-3 years of Cell Therapy or Biologics Regulatory CMC experience, including the preparation of Cell Therapy or Biologics CMC dossiers
At least a bachelors degree required.

Skills/Knowledge Required:

REQUIRED: Experience with Cell Therapy or Biologics CMC regulatory documents (IND, IMPD, amendments, meeting requests and briefing books, responses to questions)
REQUIRED: Experience with CMC regulations for cell therapy or biological compounds
A PLUS: Experience with Cell Therapy CMC regulations
REQUIRED: Practical knowledge of FDA, EMEA, Canadian, and ICH guidelines.
A PLUS: Practical knowledge GMO or NSN applications, and of rest of world guidelines
REQUIRED: Have a solution-oriented approach to problem solving
A PLUS: Expertise in cell therapy or biologic drug development process activities
REQUIRED: Ability to work on complex projects and within cross-functional teams

Weekend work may be needed occasionally.
Pay Range:  38.81-39.00

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