The role involves providing strategic regulatory intelligence and guidance to support product development from preclinical stages through registration
Job Summary
The role involves providing strategic regulatory intelligence and guidance to support product development from preclinical stages through registration.
Candidates will act as a senior contact serving top pharmaceutical companies and biotechs across over 100 countries.
The position requires preparing and reviewing regulatory submissions while ensuring compliance with local, regional, and ICH requirements.
Matching Summary
The role involves providing strategic regulatory intelligence and guidance to support product development from preclinical stages through registration.
Skills & Requirements
Must-have
5+ years regulatory affairs experience
Bachelor's degree or equivalent
Strong English communication skills
Knowledge of ICH and global guidelines
Microsoft Office proficiency
Nice-to-have
Strategic project leadership abilities
Budgeting and forecasting experience
Training junior team members
Negotiation and problem-solving skills
Key Requirements
Bachelor's degree required
5+ years relevant experience
Solid understanding of clinical trial authorization