Loading...
SeniorFull-time
Salary Range
$49,725 - $67,275 /year
This salary is estimated based on similar roles. The actual salary may vary.
About the Role
We are looking for a Regulatory Affairs Specialist to join our Europe Area Regulatory Affairs (ERA) team. This role involves implementing regulatory strategies for products across various development stages in multiple European countries.
Key Responsibilities
- βImplement regulatory strategies and deliverables for products in early/late development or marketed phases across Europe, including EU and non-EU countries
- βManage product maintenance and lifecycle submissions in compliance with legal and regulatory requirements
- βContribute to regional process development to enhance regulatory operational efficiency
- βMaintain up-to-date knowledge of regional regulatory procedures and environment
- βServe as primary Regulatory Affairs (RA) interface with Commercial Area Brand Teams and affiliate RA personnel
Requirements
- βExperience in regulatory affairs with pharmaceutical products
- βStrong understanding of regulatory procedures in European markets
- βAbility to coordinate review of CMC, QRD, PSUR, and labelling submissions
- βExperience with drug development strategy and Scientific Advice/PIP/IMPD processes
- βExcellent communication skills for interfacing with various stakeholders
- βAbility to provide strategic input for registration and regulatory risk mitigation
- βExperience with EMA interactions and local health authorities
- βLeadership skills to support RA personnel in affiliates
- βAttention to detail for regulatory compliance and data accuracy
Free to sign up. Takes 30 seconds.
