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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

Description:
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.

Qualifications

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

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

 

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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