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CSL Confidential Active Jobs Report dated: Sunday, May 26, 2013

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 Affairs Manager, Emerging Markets

CSL Code: 7658

Job Title
Regulatory Affairs Manager, Emerging Markets
Target Compensation
Confidential
Job Type
Registration, Regulatory Affairs, Submission Compliance, System/Document Management
Location
Berkshire/Buckinghamshire, Middlesex, Oxfordshire, South London, West London, Hampshire/iow
Employment Type
Permanent Job
Employer Type
Biotech, Pharmacuetical Affiliate/Marketing Company, Pharmaceutical R&D HQ (Global Or EU)
Seniority
Team Manager/Project Manager
Duration
 
FTE Hours
Full Time 35 - 40hrs Per Wk
Vacancy Status
Open For Applications
Date Posted
Fri 17th Aug 2012, 01:16pm
Regulatory Manager (Emerging Markets ) - Permanent
Pharmaceutical company in Buckinghamshire

Introduction

Our client is a leading pharmaceutical company, located in Buckinghamshire. Working across multiple therapy areas, they research and develop both ethical and consumer health products in a range of therapy areas including dermatology, ophthalmology, neurology, medical devices and other speciality markets.

Located within easy reach of the M40, and mainline BR, our client boasts modern spacious offices with ample free car parking. Generally speaking, roles with this client are fully office based and there is limited scope for home working. Office facilities include onsite restaurant, and a relaxed 'coffee shop' area.

CSL are^privileged to have a longstanding relationship with this client and have made many placements both for permanent and contract openings so can really vouch for them when we say that candidate feedback is extremely positive and this is a great place^to work.

Our client offers a generous package, usually made up of a basic salary, performance related bonus, healthcare and generous annual leave allowance. We do regularly handle openings with this client, so if this sounds like the sort of place you would like to work, please contact Kirsty Clark directly on 01932 234681 for a confidential discussion regarding your job search.

Job Summary

Are you a Regulatory Affairs Executive with significant experience of working across Emerging^Markets?

Are you seeking a role where your efforts will be rewarded with and excellent package and great career progression?

Then read on.

My client is currently seeking a Regulatory Affairs Manager to join their Emerging Market division.^To be successful,you must have experience in working in at least one of the following areas; Eastern Europe, AsiaPAC, EMEA, Middle/Far East or Africa as well as European markets and have the ability to be office based in Buckinghamshire

Much work^is led by this company,rather than outsourced, and you will have an excellent opportunity to build on experience to date. The majority of your time will be spent determining regulatory strategy in Emerging Markets to maximise company presence and revenue. Full lifecycle product knowledge will be required as you perform lifecycle maintenance activities in addition to any initial applications.

You will have great people skills, and the ability to forge solid professional relationships with^colleagues and regulatory bodies alike. Your time management will be excellent and your project management skills solid. You should also have an in depth knowledge of Regulatory compliance across EM, as you will be required to handle multiple projects at any one time, potentially in varying regions.

Our client firmlybelieves that its staff are their best asset. Professional development is encouraged and supported for talented candidates.

Essential Skills & Qualification

A life sciences^degree will be essential for this role. The successful candidate willalso have significant experience in Regulatory Affairs, with some experience of working in Emerging Markets.

Supplementary Requirements:

Software Competence: MS Office, MS Project DOCUMENTUM
Valid Driving License: Yes
Working Language(s): English
Requirement for Business Travel: Yes - some
Flexible Working Hours: No

Employment Information:

Employer: Pharmaceutical Company
Employment Type: Permanent
Hours: Full time
Location: UK; Office Based access near M40
Plan Start Date: ASAP
Employer Benefits:
Company Pension, Company Car, Car Allowance, Life Insurance, Private Healthcare, Bonus, Childcare Vouchers. Relocation assistance may be possible

Keywords:

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

Assigned Consultant: Kirsty Clark at CSL Recruitment on 01932 234 681
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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