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