Company
DirectorGlobalRegulatoryAffairsLead(m/f/d)
“Director Global Regulatory Affairs Lead (m/f/d). Skills: Regulatory Affairs, Biosimilar Development, Global Submissions. Shape regulatory strategies. Drive regulatory strategies”
What You'll Achieve.
enabling efficient submissions; approvals; sustainable product maintenance; high-quality submissions; ensure effective implementation of feedback; proactively influence the evolving regulatory landscape; drive submissions through to approval
What You'll Do.
Shape regulatory strategies
Drive regulatory strategies
Own regulatory strategies
Execute regulatory strategies
Coordinate cross-functional activities
Lead interactions with health authorities
Ensure feedback implementation
Influence regulatory landscape
Provide global regulatory leadership
Manage submission documents
Lead meetings with Health Authorities
Develop global submission strategies
Ensure regulatory compliance
Align regulatory strategies
Gain endorsement of strategies
Define regulatory storylines
Deliver clear regulatory storylines
Collaborate with Regulatory Operations
Implement technologies
Ensure consistent systems
Provide regulatory guidance
Support global launch decisions
Support market prioritization
Lead Regulatory Sub-team
Drive submissions to approval
Manage external partners
How You'll Work.
Team & Collaboration
Coordinating cross-functional activities; Align and gain endorsement of regulatory strategies with Development Team and Biosimilar Management Team (BMT); Collaborate with Regulatory Operations; Act as key interface across regulatory and cross-functional teams
Communication Scope
Lead interactions with health authorities; Define and deliver clear regulatory storylines for authority interactions
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