Director, Regulatory Affairs Strategy
Pharmaceuticals
Director,RegulatoryAffairsStrategy
“Director, Regulatory Affairs Strategy at Director, Regulatory Affairs Strategy. Skills: Regulatory affairs strategy, Clinical submissions, Regulatory compliance. Provide interpretation of feedback. Lead development of regulatory strategic plans”
What You'll Achieve.
Ensure attainment of governmental approvals
Industry & Context.
Critical thinking
Work onsite 4 days per week, Relocation support offered
What They're Looking For.
Must Have
MD, Ph. D. or Pharm D. degree, 10 years pharmaceutical industry experience, 7 years regulatory experience
Nice to Have
Interacting with CROs, Management of ex-US/ex-EU CTAs
What You'll Do.
Provide interpretation of feedback
Lead development of regulatory strategic plans
Own preparation of major clinical submissions
Work with project teams to resolve issues
and communicate requirements
Ensure attainment of governmental approvals
Responsible for quality of IND/CTA submissions
Responsible for timeliness of IND/CTA submissions
Responsible for quality of BLA submissions
Responsible for timeliness of BLA submissions
Interact with other functions and partners
Prepare documents for regulatory submissions
Review documents for regulatory submissions
Complete documents for regulatory submissions
Prioritize activities
Assure compliance with regulations
Assure compliance with project team timelines
Provide interpersonal support
How You'll Work.
Team & Collaboration
Project teams; Other functions; Partners
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
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