Job description

Requirements

  • Entry level
  • No Education
  • Salary to negotiate
  • ESSEX - ESSEX - GB

Description

We are currently looking for a Regulatory Affairs Senior Officer to join a leading Regulatory Consultancy company based in the Essex area. As the Regulatory Affairs Senior Officer you will be responsible for a range of Regulatory activities to support Pharmaceutical clients.

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Regulatory Affairs Senior Officer will be varied however the key duties and responsibilities are as follows:

1. Preparation & project management of Marketing Authorisation Applications (MAA)

2. Authoring of CMC documentation and responses to questions, as required

3. Preparation and authoring and/or review of post-approval submissions (e.g. variations, renewals, PSURs, artwork updates)

4. Preparation, update or review of PI texts (including co-ordinating linguistic review processes)

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Regulatory Affairs Senior Officer we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Science discipline (e.g. Biology, Chemistry etc.) in addition to hands on experience of Regulatory Affairs activities with a focus on small molecule Pharmaceutical products

2. Proven industry experience in a Regulatory Affairs position where you are working to EU requirements including knowledge of MRP, DCP and CP procedures.

3. A working knowledge and practical experience with product Life Cycle management including Variations and renewals.

Key Words: Regulatory Affairs | Officer | Associate | Life Cycle Management | Variations | Renewals | MAA | Marketing Authorisation Applications | CMC | PSURs | Artwork updates | Post-approval submissions

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

  • scientists and researchers