As a Regulatory Affairs Manager, you'll offer innovative solutions, including regulatory affairs expertise and client interface, to provide strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization.
- Own regulatory decision-making for assigned clinical trials and programs, ensuring decisions are consistent with the agreed indication-level regulatory strategy.
- Translate the agreed indication-level strategy into an actionable trial-level regulatory strategy and execution plan, defining regulatory pathways, priorities, deliverables, dependencies, risks, and timelines.
- Provide strategic regulatory intelligence, guidance, and technical expertise to internal and external stakeholders on projects of moderate to high complexity.
- Maintain current knowledge of applicable legislation, regulatory requirements, guidelines, and emerging regulatory developments and translate these into relevant strategic and operational guidance.
- Serve as a regulatory subject-matter expert across global, regional, and country-specific requirements.
- Bachelor’s degree or equivalent relevant formal academic/vocational qualification
- Nice to have: Platform Protocols
- Nice to have: Integrated Protocol Designs
Partnerships Manager (SMB)Vendelux · New York, US