3 months ago
Job title: Senior Regulatory Affairs Officer
A global Pharmaceutical business in Berkshire are seeking a Senior Regulatory Affairs Officer. In this role you will maintain marketing applications, develop submission strategies and gain marketing authorisations for new countries. Working in a small team you will report directly into the Senior Regulatory Affairs Manager - giving you great opportunity to learn and develop your career within Regulatory Affairs.
- Prepare, submit and coordinate national Marketing Authorisation Applications
- Gain marketing authorisations for pharmaceutical products in new countries
- Compile regulatory documents in eCTD format
- Develop submission strategies for all CMC and safety changes
- Development and maintenance of regulatory Standard Operating Procedures
- Experience dealing with multiple health authorities
- Degree in life sciences
- Experience submitting new MAAs
- Previous experience maintaining existing marketing authorisations
Salary and benefits:
A competitive salary, annual bonus and private medical insurance are on offer.
To apply for this position or hear further details then please contact Matt Thomas via email@example.com