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CMC Lead - Regulatory Affairs
Ref No.: 18-00020
Location: Lexington, Massachusetts
Start Date: 08/08/2018
Interested candidates please submit your profile to kiran@starkassocaitesllc.com

Description:
•    The CMC Regulatory Affairs IgMAX Regulatory CMC strategy Team Lead will provide leadership and be the Regulatory CMC point of contact for major projects in the Plasma OpU, including but not limited to, site-to-site technical transfers, QC transfers, changes to external network, and internalization of manufacturing. This will include formulating and implementing CMC regulatory strategies, lead CMC regulatory activities for assigned projects in line with US or ICH requirements, using contemporary submission standards, and owning all aspects of Modules 2.3/3. 

•    Primary role includes: 
  • Serve as the team lead for IgMAX projects 
  • Serve as a liaison between the project teams and the GRA CMC Product Lead 
  • Provide CMC RA leadership within RA and on cross-functional CMC teams 
  • Maintain up-to-date knowledge and expertise of relevant FDA, EMA, Canada and ICH guidelines and regulations 
•    Provide CMC regulatory strategy for proposed changes or other related activities for commercial programs. (60%) 
•    Facilitate timely regulatory approvals by ensuring the quality and appropriateness of submission documents, and maintaining regulatory compliance for marketed products (15%) 
•    Lead other functions for preparation of high quality regulatory submissions including CMC sections of IND, CTA, IMPD. BLA, MAA, NDA, and NDS and their amendments/supplements. (15%) 
•    Evaluate manufacturing change controls, assess regulatory impact, and support their implementation. (10%)