Director, Regulatory Affairs - CMC (Cell Therapy)

The Director, Regulatory Affairs - CMC (CGT) is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of AstraZeneca's Cell and Gene Therapies (CGT). This position may be based in Santa Monica, CA or Gaithersburg, MD and reports to the Senior Director, CMC Regulatory Affairs (CGT).  

Essential Functions and Responsibilities   

• Provide strategic guidance during all stages of product development and lead the development and implementation of global CMC regulatory strategies for the pipeline of AZ cell and gene products.

• Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams.

• Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / BLA/ Master Files, amendments, annual reports) and health authority interaction briefing documents. Manage and maintain regulatory dossiers as required throughout the product development lifecycle.

• Represent CMC regulatory affairs on product teams and in health authority interactions. 

• Provide review and compilation and ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity, and accuracy.

• Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises. 

• Support the development and maintenance of regulatory templates, best practices, and procedures. 

• Support hiring, leading and managing workflow and development of staff.  

• Perform other duties as required. 

Education & Experience

• Degree in life sciences required, advanced degree preferred (PhD, PharmD).

• Experience of 10+ years with BS/BA; 8+ years with MS/MA or MBA; 6+ years with PhD. 

• Prior experience in cell/gene therapy. 

• In depth knowledge of global CMC regulations and understanding of evolving challenges and health authority expectations for cell therapies. 

• Experience in IND, IMPD, BLA, MAA filings. 

Skills/Abilities    

• Demonstrated ability to develop/maintain strong working relationships with the cross functional teams, participate on and/or lead multi-functional teams, handle, and prioritize multiple projects and work independently.

• Excellent communication and collaboration skills to work in a fast-paced start up environment. 

• Proficient leadership skills to successfully lead complex programs. Able to effectively build and lead high-functioning teams.

• Ability to deal with time demands, incomplete information or unexpected events 

• Attention to detail and outstanding organizational skills with the ability to multi-task and prioritize. 

#CellTherapy #LI-Hybrid

The annual base pay for this position ranges from 186,232.80 - 279,349.20 USD. Base pay off