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We have an immediate opening for an Associate Director, Regulatory Affairs (CMC/Biologics) at our US headquarters.

The Associate Director Regulatory Affairs (CMC/Biologics) will be proactive in helping to provide strategic CMC direction in the implementation of quality strategies, policies, procedures and optimal infrastructure to ensure systems are aligned with company submissions, LFB Corporate Quality, and applicable external regulatory authorities.   This person/position will work closely with a number of LFB France groups providing guidance and expertise on CMC matters and will work closely with internal LFB Regulatory groups/personnel and provide input/writing/review of CMC sections of filings. This person/position may be asked to represent or participate in LFB for Regulatory Agency interactions (correspondence, conference calls, in-person agency meetings, etc.). At the Associate Director level, this person/position will demonstrate expertise in US and global regulatory principles, particularly for CMC issues, and specifically around biological products development and lifecycle management, for the benefit of collaborating with multi-functional, multi-disciplinary colleagues, partners, and stakeholders throughout the LFB organization.