Senior Regulatory Officer, Regional Labeling

Key People

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Job ID :

8682


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Bsc


Address 1 :

United Kingdom,Hertfordshire,Hertfordshire,


Key Skills :

regulatory, labeling, labelling, smpc, pils, pil, cmc, eu, registration, post approval


Salary :

£35000 - £44000 per annum


Date Posted :

13 Sep, 2017



Company Name :

Key People


Location1 :

Hertfordshire




Job Category :

Regulatory Affairs Jobs


Experience :

Fresher


Job Type:

Permanent


Travel Amount:

negotiable





Description

An excellent opportunity has arisen for an experienced and driven candidate to join the labelling team within a global healthcare company based in Hertfordshire. You will be responsible for authoring and maintaining SmPCs and PILs, as well as responding to questions from authorities and supporting central regulatory teams.

Responsibilities:
*Connect, collaborate and communicate with internal and external customers to achieve business goals
*Member of a dedicated Regulatory team managing safety updates to product information for the European generic portfolio
*Authoring and maintenance of the SmPC, Package Leaflet (PL) and Labelling in compliance with the reference product, other safety information, CMC and relevant Labelling legislation and guidelines
*Responding to questions and requests from European health authorities and the EMA
*Supporting the Central Regulatory team with submission-ready documents and strategy

Experience Required:
*Experience in Regulatory affairs, preferably including management of Labelling documents
*Knowledge of the lifecycle and maintenance of product information
*Understanding of key legislation, templates and guidelines governing Labelling within Europe
*Proficiency in speaking, comprehending, reading and writing English

For further details, please contact Tim Barratt on (0)1727 817 626 or email your CV to 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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