Regulatory Affairs Officer - EU Submissions

Key People


Job ID :

9165


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,--East London,East London,


Key Skills :

regulatory, regulatory officer, senior officer, registrations, post approval, MAA, variations, EU, p


Salary :

£30000 - £35000 per annum + benefits


Date Posted :

19 Oct, 2017



Company Name :

Key People


Location1 :

East London




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experienced Regulatory Affairs Officer to join the EU team at one of the largest pharmaceutical companies in the world. Within this role you will be responsible for registrations and life cycle maintenance across Europe and will have the opportunity to progress your career and take on more responsibility as your experience grows.

To be considered for this role you will be educated to BSc (Hons) level (or equivalent) and ideally have knowledge of regulatory affairs and the pharmaceutical industry, ideally with good knowledge of EU regulatory procedures and requirements. Excellent verbal and written skills are essential as communication will play a key part in this in this role.

Main Responsibilities:

-Submission of new generic Marketing Authorisation Applications for a wide variety of products. Doseage forms will include; tablets, modified release capsules, injectables and oral solutions. These are registered through Centralised, Decentralised or Mutual Recognition Procedure.
-You will work closely with your manager and the R&D sites to support the preparation, compilation, review and submission of high quality regulatory dossiers
-Post marketing documentation maintenance and submission in accordance with EU requirements.
-You will also support regulatory submissions from development through to first launch, taking an active role in the project team.

Experience:

-You will ideally have previous EU exposure and have 1-3 years of regulatory experience
-MRP/DCP submission experience, end to end.
-Ideally previous generics experience
-Strong communication skills
-BSc (Hons) or equivalent

For further details about this role, or other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk.


Company Name:

Key People


Headquarters:

Catherine House,Adelaide Street


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

AL3 5BA


Website:

www.keypeople.co.uk


Employees:

less than 100


Industry:

Pharmaceutical


City:

St Albans


Phone No. :

01727 817 626


Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit www.keypeople.co.uk.

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