Regulatory Affairs Manager

Location
Essex
Salary
Competitive
Posted
11 Jul 2018
Closes
08 Aug 2018
Ref
J562527
Contact
Georgia Walden
Contract Type
Permanent
Hours
Full Time
An exciting opportunity has become available to join a leading Regulatory Consultancy as their Regulatory Affairs Manager in the Essex area. As the Regulatory Affairs Manager you will be responsible for the line management and assignment of workloads for your team as well as acting as the point of contact for clients on a range of Pharmaceutical based projects.

KEY DUTIES AND RESPONSIBILITIES:

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

1. Line Management of staff including setting workloads and time lines as well as review and QC checking of Regulatory Documentation.

2. You will write and review a range of regulatory documentation involved in Pharmaceutical product Marketing Authorisation Applications including but not limited to Clinical Trial Applications, Patient Information Leaflets, Module 2 and module 3 documentation.

3. Write sections of dossiers for Mutual Recognition/Decentralised procedures and Centralised procedures and coordinate procedures through EU approval

4. You will also write regulatory plans and strategy reports in addition to keeping an up to date knowledge of current legislation in relation to Regulatory requirements.

ROLE REQUIREMENTS:

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

1. Relevant degree in a Life Sciences discipline (e.g. Chemistry, Biology, Pharmacology etc.) in addition to extensive experience within Regulatory Affairs, ideally with a varied background of experience (e.g. variety of products, regulatory boards and regulatory documentation).

2. Proven industry experience in a Pharmaceutical setting is required, ideally with a knowledge of a variety of therapeutic areas. A strong understanding of Post Marketing procedures is beneficial and experience with National, Centralised and International MAA's will help with your application

3. A working knowledge and practical experience with Line Managing a team of regulatory officers is essential for your application.

Key Words: Regulatory Affairs , Pharmaceutical Products , Management , Leadership , Regulatory Strategy , Variations , New Product Submissions , Module 2 , Module 3 , Clinical Trial Applications , Mutual Recognition , Decentralised Procedures , Centralised Procedures , MAA , EMA , FDA , MHRA , Dossier Submission , PIL

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.