Regulatory Affairs Officer

Location
West Sussex
Salary
Dependent on experience
Posted
09 Feb 2017
Closes
09 Mar 2017
Ref
J2966
Contact
Gemma Everitt
Contract Type
Permanent
Hours
Full Time
Hyper Recruitment Solutions are currently looking for a Regulatory Affairs Officer to join a leading biological pharmaceutical company based in the West Sussex area. The purpose of the role is to perform the activities within a Global Regulatory Affairs team. As the Regulatory Affairs Officer you will be responsible for

KEY DUTIES AND RESPONSIBILITIES:

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

1. You will write full Drug Substance sections for Module 3 of CTDs, and compile Type II, IB and IA variations to National Marketing Authorisations held throughout the EU.

2. As the Regulatory Affairs Officer you will prepare full response to deficiencies received from AIFA in regard to an MAA.

3. You will be responsible for the preparation and submission of renewals in the EU, and preparation of the annual TSE report.

4. As the Regulatory Affairs Officer you will review UK promotional material in line with the Blue Guide and ABPI.

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 scientific discipline.

2. Proven experience in a global regulatory environment.

3. Practical experience of preparing dossiers and documents for importation licenses for emerging markets such as Latin America, and a good knowledge of GMP.

Key Words: Regulatory affairs, biologics, pharmaceutical, global, clinical trial application, variations, dossiers

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer that is happy to 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 scientists supporting science. We look forward to helping you with your next career moves.