Regulatory Executive (CMC), Emerging Markets
Major Pharmaceutical Company based in Berkshire
Rolling 12 Month Contract
Globally, my client is the world largest research based pharmaceutical company. Established for over 150 years, my client employs approaching 5000 staff on both a contract and permanent basis- and that's just in the UK! Located in the South East, my clients offices are modern and spacious, with ample free parking, onsite restaurant and are within easy reach of mainline BR.
Working across a variety of therapy areas, my client has changed 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.
If you are looking for a role which will provide you with variety and challenge then this could be for you.
Working across global markets (including emerging markets) you will be responsible for the management and creation of CMC documents for initial submissions and established products.
A natural problem solver, you will play a key role in assisting the regulatory team in responding to CMC related questions and adapting your skills to other regulatory tasks as required.
Essential Skills & Qualification
BSc or higher in life^sciences or related discipline
Significant experience of working within Regulatory Affairs
Previous experience in EU / EM market primary applications
Excellent knowledge of Documentum
Software Competence: MS Office, DOCUMENTUM
Valid Driving License Not Required
Working Language(s): English
Requirement for Business Travel: Yes
Flexible Working Hours: To be confirmed
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 12 Months
Location: UK; Office Based access near M3/M4
Plan Start Date: 25th June 2012, Please do not apply if you are unable to meet this start date.
Contract Benefits: Day Rate inclusive of benefits
DOCUMENTUM, Registration, Regulatory Affairs, MAA, CMC, Expert Reports, Clinical Trial Applications, CTA, CPMP, Dossier, Regulatory Agency, Documentum
Assigned Consultant: Kirsty Clark at CSL Recruitment on 01932 234681
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.