Key skills
CommunicationCollaboration
About this role
Role Overview
- Contribute to preparation and delivery of regulatory submissions from a global and regional perspective
- Preparation and review of Marketing Authorization Applications & Variations for filing in US, EU, Japan, Canada Switzerland, Australia
- Guide/mentor team members on technical aspects including regulatory filings to global markets
Requirements
- 10 to 14 years of relevant experience
- Minimum of a bachelor’s degree in a Scientific or Technical Discipline
- Extensive experience in managing new registrations, life cycle maintenance, and renewals for biological products
- Good understanding of regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules
- Strong communication and collaboration skills
- Ability to work independently
Benefits
- Flexible work arrangements