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.

Responsibilities:

• 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

Requirements:

• 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 matt.thomas@pharma-partners.co.uk