Regeneron
AssociateDirector,CMCRegulatoryAffairs(Hematology/Oncology)
“Associate Director, CMC Regulatory Affairs (Hematology/Oncology) at Regeneron. Skills: CMC regulatory affairs, Hematology/Oncology, Regulatory strategy. Lead development and execution of global CMC regulatory. Guide regulatory activities across development stages”
Industry & Context.
Identify program issues; Develop regulatory strategies; Mitigate risks; Find alternative solutions; Obtain consensus
On-site 4 days in office (US), On-site 3 days per week (UK/Ireland)
What They're Looking For.
Must Have
Bachelor's degree, 10 years pharmaceutical/biotech industry experience, 5+ years relevant CMC experience, Good understanding of current CMC worldwide regulations and guidelines, Experience interacting with US FDA
Nice to Have
Advanced degree, Proven track record supporting biological products through development and approval, Experience with device regulatory requirements for combination products, Experience with development processes for combination products
What You'll Do.
Lead development and execution of global CMC regulatory
Guide regulatory activities across development stages
Mentor CMC Regulatory Affairs staff
Support cross-functional and external partners
Serve as liaison in regulatory authority interactions
Lead product development activities from CMC regulatory standpoint
Represent CMC RA at program meetings
Provide regulatory interpretation and position
Cover clinical development
Cover initial market applications
Cover approval/post-approval activities
Identify program issues
Develop regulatory strategies to mitigate risks
Find alternative solutions/work-arounds
Review and provide input on regulatory filing documents
Facilitate development
and marketing of drugs/biologics
Lead and facilitate interactions with global regulatory authorities
Perform final review and approval of compliance activities
Confirm regulatory impact and submission requirements
Mentor colleagues in compliance assessment discussions
Find opportunities for improvement of processes
Develop and create working instructions
Develop and create SOPs
Develop and create templates
Identify gaps in IOPS and global RA processes
Bring gaps to higher management
Help to improve business efficiency
Support establishing knowledge base of regulatory requirements
Support maintaining knowledge base of regulatory guidelines
Find opportunities to initiate operational changes
Find opportunities for policy modifications
Manage team member(s)
How You'll Work.
Team & Collaboration
Cross-functional teams; External partners; Regulatory authority interactions
Communication Scope
Regulatory interpretation; Regulatory position
Process & Methodology
Managing multiple priorities
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