Regulatory Affairs Officer

Location
Berkshire
Salary
Dependent on Experience
Posted
16 Sep 2020
Closes
16 Oct 2020
Ref
J5633800
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
We are currently looking for a Regulatory Affairs Officer to join a leading Pharmaceutical company based in the Berkshire area. As the Regulatory Affairs Officer you will be responsible for the preparation and submission of new Marketing Authorisations as well as product maintenance variations.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Preparation and Submission of Marketing Authorisation Applications to MRP, DCP and National procedures.

2. Preparation and submission of product variations including Safety Variations, CMC Variations , Renewals and artwork and labelling changes.

3. Lead the Regulatory approval process for line extensions and life cycle management activities.

4. Work closely with the Regulatory Affairs Manager to ensure compliance of all regulatory activities and raise Change Controls as appropriate.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline with previous Regulatory Affairs experience. Ideally looking for 2 years+ within the Pharmaceutical industry but OTC and Generics will also be considered.

2. Proven industry experience of handling Regulatory Submissions to UK and Ireland authorities, where experience of EU and Global markets would be beneficial.

3. A working knowledge and practical experience with Life cycle maintenance and post marketing authorisation is important where you have dealt with Health Authorities to negotiate and agree positive submissions.

Key Words: Regulatory Affairs | MAA | Post Marketing Authorisation | Life Cycle Management | Variations | Renewals | Submissions | EU | UK | Pharmaceutical | OTC | Genetic | Regulatory Affairs Officer

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.

Apply for Regulatory Affairs Officer

Already uploaded your CV? Sign in to apply instantly

Apply




Upload from your computer

Or import from cloud storage

Your CV must be a .doc, .pdf, .docx, .rtf, and no bigger than 1MB


4000 characters left

Marketing Communication

We'd love to send you information about Jobs and Services from Chemistry World Jobs by email.

All emails will contain a link in the footer to enable you to unsubscribe at any time.


When you apply for a job we will send your application to the named recruiter, who may contact you. By applying for a job listed on Chemistry World Jobs you agree to our terms and conditions and privacy policy. You should never be required to provide bank account details. If you are, please email us.

Similar jobs

Similar jobs