Regulatory Affairs Officer

Location
Surrey
Salary
Competitive
Posted
14 Nov 2018
Closes
12 Dec 2018
Ref
J563241
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
An exciting opportunity for a Regulatory Affairs Officer has become available at a Generics Pharmaceutical company based in Surrey. As the Regulatory Affairs Officer you will be responsible for coordination and contribution to the Regulatory activity, which includes working closely with Regulatory Consultants, R&D sites and 3rd-Party partners. Due to the varied nature of the role, there will be the opportunity for exposure to a wide range of regulatory issues and procedures.

KEY DUTIES AND RESPONSIBILITIES:

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

1. The coordination of Regulatory activity and the support of the preparation, compilation, review and submission of Marketing Authorisation Applications to EU markets under Decentralised Procedures.

2. Support the post-marketing activity for current licences with the MHRA and other global regions.

3. Assist with the preparation of CMC / Module 3 documentation including liaising with CMO's.

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 (e.g. Chemistry, Pharmacy, Pharmacology etc.) in addition to knowledge of Regulatory Activity.

2. Proven experience in a Regulatory focused role, ideally with knowledge of EU procedures and requirements. Experience with Generics will be beneficial but not required.

Key Words: Regulatory Affairs | MAA | Generics | CMC | Module 3 | Submissions | Variations | Renewals | DCP | Decentralised Procedures | EU | MHRA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant 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 processionals and scientists. We look forward to helping you with your next career moves.

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