Beeline Medicines
Biotechnology
AssociateDirector,RegulatoryStrategy
“Associate Director, Regulatory Strategy at Beeline Medicines. Skills: Regulatory strategy, Regulatory affairs. Develop regulatory strategies. Implement regulatory strategies”
Industry & Context.
What They're Looking For.
Must Have
7 years regulatory affairs experience (Bachelors), 5 years regulatory affairs experience (Masters), 3 years regulatory affairs experience (Doctoral), Experience with Type meeting processes, Experience with briefing document preparation, Understanding of ICH guidelines, Understanding of 21 CFR Parts 312, Understanding of 21 CFR Parts 314/601, Understanding of international regulatory frameworks, Experience with biologics (mAbs, fusion proteins, large molecules), Comfort operating in ambiguous environments, Comfort operating in high-growth environments, Ability to build effective partnerships, Flexibility and adaptability, Commitment to integrity, Ability to work efficiently, Excellent written communication, Excellent verbal communication, Ability to synthesize complex regulatory information
Nice to Have
Advanced degree (MS, PhD, PharmD) preferred, Focused on regulatory strategy preferred
What You'll Do.
Develop regulatory strategies
Implement regulatory strategies
Coordinate ex-US regulatory activities
Support ex-US regulatory interactions
Ensure consistency with regulatory strategy
Serve as regulatory representative
Ensure alignment on regulatory issues
Ensure alignment on regulatory risks
Ensure alignment on regulatory timelines
Communicate regulatory requirements
Communicate regulatory risks
Communicate regulatory opportunities
Partner with Medical Writing
Ensure regulatory compliance
Ensure quality across submission documents
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Cross-functional program teams; Regional leads; CROs
Communication Scope
Synthesize complex information
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