European Regulatory Lead
Large Bio-tech based in Cambridge
Contract role - 12 Months
Introduction
My client is a leading Fortune 500, Biotechnology Company. With headquarters in the USA, my client employs over 500 staff in their UK offices,^located in Cambridge and Middlesex onboth a permanent and contract basis.
A market leader, my client strives to develop products that change people's lives and in the last 30 years have transformed the management of anaemia, inflammation, and cancer. They have a thriving pipeline and are currently very active in recruiting candidates to join the team on a contract basis.
Both UK sites are easily reachable by mainline BR and have excellent road links with ample free car parking.
My client knows they offer a great place to work. My client understands that each candidate is not the same, and no two roles are either. That's why they permit up to two days working from home per week depending on the role. Moreover, it's a place where^you will be more than a contractor-you will be one of the team, and that even means an early Friday finish!
Job Summary
Located in the Cambridge office, my client is seeking a Senior Regulatory Manager to join the team. The successful candidate will be someone who is happy to 'roll up their sleeves' and muck in. This role is varied. The successful candidate will be working on a portfolio of both development and marketed products in Oncology, so complete lifecycle experience from CTA applications through to MAA applicationsand post marketing activities is essential.
Although working predominantly in EU markets, you should also have some experience in working across international markets, particularly in the review and approval of^promotional and non promotional materials. This role also contains a substantial amount of strategy development and implementation, in order to optimise product development.
Essential Skills & Qualification
- BSc (or higher) in related subject
- Proficient in submitting CTAs
- In depth understanding of the VHP.
- Experienced in promotional and non promotional material review, lifecycle maintenance including renewals, variations and line extensions
- Ability to communicate effectively and clearly across all levels
- Time management skills and the ability to prioritise workload.
Supplementary Requirements:
Software Competence: MS Office, MS Project, DOCUMENTUM
Valid Driving License: Not Required
Working Language(s): English
Requirement for Business Travel: Limited travel may be required
Flexible Working Hours: To be confirmed
Employment Information:
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 12 Months^
Location: UK; Office Based inCambridge
Plan Start Date: ASAP
Contract Benefits: Day Rate inclusive of benefits
Keywords:
MS Office, MS Project, 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 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.