BLA/CMC Program Manager-Regulatory Affairs

Dedham, MA
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Type: Direct-Hire

Category: Scientific & Clinical

Job ID: 140873

Date Posted: 05/17/2019

BLA/CMC Program Manager-Regulatory Affairs

- BS degree in scientific field

Experience/"MUST HAVES":
- Minimum of 10 yrs. exp. in the Med Device and/or Life Science industry
- Minimum of at least 5 yrs. exp. with increasing responsibility in Regulatory Affairs
- Solid exp. and knowledge of device/biologic development process and of FDA regulatory requirements for biotech products in the U.S. is a Must
- Exp. with technical aspects of product development and manufacturing
- Exp. successfully submitting regulatory filings to the FDA and other regulatory agencies. 
- Exp. working on INDs and BLA submissions


- Responsible for regulatory submissions for bio-technology products including cell-based & tissue derived products. Includes preparation writing & submission of IND & BLA applications as well as other submission types for products approved/cleared through PMA & 510(k) pathways
- Interact with government agencies & regulatory authorities, as necessary, to facilitate submission review & product approvals, maintain compliance & communicate pertinent information. Plan & participate in meetings with FDA & provide regulatory support for inspections by government & other regulatory authorities
- Will lead the US Regulatory Affairs program for development of multiple cell-based products through the clinical phases and submission of a Biologics Licensing Applications (BLA).
- Leading the preparation & submission of Investigational New Drug (IND) & BLA applications, with overall responsibility for submissions & writing of Chemistry Manufacturing Controls (CMC) sections
- Collaborate with Quality Systems to manage and maintain compliance of systems and processes with GMP/ QSR requirements, applicable international requirements and industry standards. Development, writing and review of SOPs and protocols to ensure regulatory compliance
- Lead/manage complex issues with multiple competing priorities that have a direct impact on operations and opportunities. Provide organization and prioritization to align with business needs
- Willing to set and drive aggressive project timelines

Location:  Canton, MA area
Start Date: ASAP!!!
Duration: Direct Hire

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