Remote - Director, Regulatory CMC (Cell Therapy)

Insight Global
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Job Details

  • Location: La Jolla, CA, 92037
  • Date Posted: 2022-05-05
  • Employment Type: Full Time
  • Category: Education
  • Req Number: 153797
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Insight Global is looking for a Remote Director of Regulatory CMC for Cell Therapy. This role is accountable for the execution of CMC regulatory activities in support of the company's vision for building a network of high-tech, end-to-end manufacturing operations and development solutions across multiple drug product modalities.

Responsible for conducting impact assessments and providing regulatory guidance during the implementation of GMP-related changes. Work cross-functionally across the company's network and Clients. The Director, Regulatory CMC is a key leadership role and reports to the Vice President (Head of), Regulatory.

* Demonstrated experience in cell therapy product approval is preferred
* Minimum of 15 + years of pharmaceutical industry experience, with a minimum of 12+ years in a Regulatory CMC role; experience in biologics and cell therapy operations is required

* Demonstrated, hands-on experience in drug development CMC, registration, and post-approval life cycle management in a global regulatory environment

* Excellent knowledge of the regulations related to cell therapy-related products

* Experience with drug product manufacturing facility licensure

Strong knowledge of current Good Manufacturing Practices (GMP); experience with on-site regulatory inspections is required

* Ability to understand and interpret complex scientific issues across multiple projects as it relates to regulatory requirements and strategy

*Demonstrated experience in preparing regulatory submissions and response to health authorities queries

*Ability to influence without direct authority

*Demonstrated excellent collaboration skills

* Excellent verbal and written communication and skills

* Ability to work independently and collaboratively in a fast-paced, matrixed, team environment