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Regulatory CMC

San Diego, CA 92121

Posted: 06/05/2023 Employment Type: Contract Job Category: Regulatory Sciences and Medical Writing Job Number: 567937 Is job remote?: No Country: United States

Job Description

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:

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

50-56 pay rate range
**salary will be commensurate with experience**

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