The Regulatory Affairs Manager will lead global regulatory strategies and ensure alignment with cross-functional stakeholders across Emerging Markets
Job Summary
The Regulatory Affairs Manager will lead global regulatory strategies and ensure alignment with cross-functional stakeholders across Emerging Markets.
This role involves representing Regulatory Affairs in senior internal forums and providing authoritative regulatory insight to support program progression and decision-making.
The position requires driving continuous improvement initiatives to streamline regulatory processes and enhance operational efficiency.
Matching Summary
The Regulatory Affairs Manager will lead global regulatory strategies and ensure alignment with cross-functional stakeholders across Emerging Markets.
Skills & Requirements
Must-have
Global regulatory strategy development
Cross-functional leadership and collaboration
Regulatory submissions and dossier management
Health Authority engagement and briefing
Lifecycle regulatory compliance
Regulatory risk assessment and mitigation
Nice-to-have
Continuous improvement and operational excellence
In-licensing regulatory evaluation
Strategic business partnership
Scientific evidence evaluation
Regulatory intelligence translation
Key Requirements
Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology or related
Advanced degree strongly preferred
Experience with global regulatory submissions
Expert knowledge of regulatory guidelines
Ability to operate autonomously with minimal supervision