Manager, Global Regulatory Strategy
Core
Regulatory strategy lead supporting clinical trial and registration activities for medicinal products across muscle, CNS, and cardiac diseases.
Role type
Manager, Global Regulatory Strategy
Builds
Regulatory submissions and strategies for assigned markets and products
Domain
Biopharmaceuticals / Gene Therapy / Duchenne Muscular Dystrophy
Required skills
Drug development knowledge, ICH guidelines expertise, IND/CTA preparation, Orphan drug designation, Cross-functional project management, Regulatory submission formatting, Market regulatory procedure knowledge, Documentation management, Adaptive communication, Multi-tasking
Preferred skills
Experience with CROs, Project timeline management, Complex information organization
Technologies
Microsoft Office (Word, Excel, Outlook), Adobe Suite
Responsibilities
Lead regulatory affairs for clinical trial activities including CTA planning and agency query responses, Review regulatory submission materials prepared by CROs, Implement regulatory activities for product lifecycle, Ensure country-specific submission preparation, Support global regulatory strategy definition, Maintain relationships with GRA and stakeholders, Provide regulatory guidance on clinical trial activities, Ensure compliance with regulatory expectations and SOPs, Develop knowledge of evolving regulations
Seniority
Manager, hands-on IC