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