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Review more information or apply at http://www.cslrecruitment.com/. Search for the CSL 4 digit code in orange using our Quick Job Search. To discuss a role, call our Candidate Hotline: 01932 219 320. Job status changes by the minute on the site and we recommend you apply via the site to ensure status is still 'Open for Applications'.

Regulatory Manager, Labelling - EMEA region, £££

CSL Code: 7551

Job Title
Regulatory Manager, Labelling - EMEA region, £££
Target Compensation
Day Rate/Negotiable, Confidential
Job Type
Registration, Regulatory Affairs, Submission Compliance
Location
Berkshire/Buckinghamshire, Middlesex, Surrey, Central/City, East London, North London, South London, West London, Hampshire/iow, Kent, Sussex
Employment Type
Temporary Contract
Employer Type
Biotech, Pharmacuetical Affiliate/Marketing Company, Pharmaceutical R&D HQ (Global Or EU)
Seniority
Senior Executive/Team Leader, Team Manager/Project Manager
Duration
12 - 18mths
FTE Hours
Full Time 35 - 40hrs Per Wk
Vacancy Status
Open For Applications
Date Posted
Wed 25th July 2012, 10:38am
Labelling Manager - Global Markets
Major Pharmaceutical Company, Office-based in Surrey
12 month Contract, great pay rate

Introduction

Globally, my client is the world largest research based pharmaceutical company. Established for over 150 years, it employs approaching 5000 staff on both a contract and permanent basis - and that's just in the UK! Located in the South East, the offices are modern and spacious, with ample free parking, onsite restaurant and are within easy reach of mainline BR. There are also shuttle buses to the site from South London and Surrey regions which are free.

Working across a variety of therapy areas, my client has changes millions of peoples lives, by assisting the fight against diseases such as Alzheimer's disease and cancer. Product portfolio stretches across animal health, consumer healthcare, generics, nutrition and prescription medicines. They have an active pipeline and are seeking talented candidates to join the regulatory affairs team on a^contract basis.

Job Summary

As a Labelling Manager based within the regional HQ, you will be responsible for overseeing labelling projects for assigned products within a geography, you will work with local operating companies to standardise^where possible and to build best practice for the brand and business. You will be one of a successful newly formed team who have 'gelled' over the last 6 months and enjoy a varied and demanding job where teamwork and mutual learning is enabled.

This role involves acting as a subject matter expert, responding to questions from affiliates and regulatory agencies relating to labelling. Your project management skills will be put to good use, tracking labelling and product progress using the in house tracking system and communicating with local SMEs to ensure latest changes are adopted.

The ideal candidate will be expert in labelling in a region, at present we are looking for people with EU/Middlle East/Africa knowledge, you must be a team^player - you will be working closely with both internal departments, stakeholders and regulatory bodies, so excellent communication skills are essential. Although you will be part of a team, my client is seeking candidates who can work with a good degree of autonomy, and be self sufficient in updating regulatory documents to include PIL and technical leaflets/documentation globally.

Essential Skills & Qualification

A degree in life sciences or pharmacy will provide a good foundation for this post. The successful applicant will also have some experience of working within regulatory affairs, and experience in working specifically with labelling will be advantageous.

Supplementary Requirements:

Software Competence: MS Office, MS^Project, DOCUMENTUM
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: Yes - some occasional travel may be required
Flexible Working Hours: Yes flexible hours

Employment Information:

Employer:^Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 12 Months
Location: UK; Office Based access near M25
Plan Start Date: ASAP
Contract Benefits: £££ Day Rate inclusive of benefits

Keywords:

MS Office, MS Project, DOCUMENTUM, Labelling, Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, Dossier, Regulatory Agency,

Assigned Consultant: Sue Spice at CSL Recruitment on 01932 228 928
Please feel free to call for a detailed Job Description or additional information

Applications are reviewed within 24hrs, applicants will only receive feedback if they demonstrate the skills the role requires in their application. The role may be remarketed; if you^applied for this role previously and were unsuccessful you will not receive a response. We request that non EU Nationals include evidence of right to work in the country concerned with their application to be considered. Do supply supplementary information on required location, notice period and expected salary/day rate if you are a new candidate.

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