Regulatory Affairs Manager II, Emerging Markets
Contract Role - 12 Months
Biotech Company, Full Time
Our 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 on both 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.
Our client knows they offer a great place to work. Our 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!
We're looking for an experienced regulatory affairs manager with Emerging Market expertise to contribute to the^MAA and post licensing life cycle management within a Therapy Area Team. You will manage one of more products under supervision and lead teams to enable satisfactory and compliant application within the international region. To function you must have good consolidated experience in supporting R&D and product lifecycle in collaborative team settings and ideally expertise working with biologics. As you will be Agency facing in this role you must be familiar with processes relating to definition of licensing strategy, clinical trials, licensing and line extension/product life cycle.
This is a broad role where you will handle significant projects and mentor and lead project teams to deliver on key components including MAAs, License Variations/Renewals/Extension, labeling changes (working with CMC) and you will also review promotional literature. The post is a collaborative remit working with remote and local teams; you will be expected to offer up advice, guidance, knowledge and training to support to optimise successful licensing within an environment of “best practice” and leading edge thinking.
Essential Skills & Qualifications Required
Life science or higher degree
Significant experience in European regulatory affairs, supporting complex submissions for either biotechnology or chemically-derived products
Oncology knowledge is desirable
Project management skills
Expertise working within a matrix organisation
Fluent English Language capability
Right to Work or Valid Visa for at least 12 months with relevant country expertise
Employer: Pharmaceutical Company
Employment Type: Agency Contract
Hours: Full time
Contract Term: 12 Months
Location: UK Office Based access M3/M4/M25
Plan Start Date: August 2012
Contract Benefits: Day Rate inclusive of benefits
MS Office, DOCUMENTUM, lifecycle, Regulatory Affairs, MAA, CMC, Dossier, Regulatory Agency, Labelling, Compliance
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.