Senior Regulatory Affairs Consultant

CK GROUP ,
High Wycombe, Buckinghamshire
More Details
Salary: £57ph PAYE or £70ph Ltd

Overview

CK Group are recruiting for a Senior Regulatory Affairs Consultant to join a company in the pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months and has a hourly rate of £57 PAYE or £70 Ltd. The Company: Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies - the largest diversified healthcare group in the world with over 100 years of scientific heritage. They employ approximately 500 people in the UK and Ireland. They are committed to delivering great medicines and have introduced a range of innovative treatments that can make an important difference to the lives of patients with serious health conditions such as schizophrenia, hepatitis C, multiple myeloma, HIV/AIDS and diabetes. The Location: Working at our clients headquarters in High Wycombe, the site is easily commutable from London and surrounding areas. The nearest station is approximately 10 minutes by taxi. If you're travelling by car you can access the site via the M40. The Role: Strategic and tactical input in development, post-approval and life cycle management. Key Responsibilities: Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates. Drive understanding of central and national regulatory requirements. Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan. Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area. Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labelling. Ensure appropriate implementation of scientific advice/Regulatory Agency comments into development and life-cycle management plan. Your Background: University degree - medical or paramedical (pharmacy, biology, veterinary etc.), or equivalent by experience. Breadth of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas). Experience with EU regulatory procedures (CP, MRP, national). Experience in working in project teams and/or a matrix organization. Previous Oncology experience required. For more information or to apply for this Senior Regulatory Affairs Consultant position, please contact CK Group, quoting job ref 47960. It is essential that applicants hold entitlement to work in the UK. This job was originally posted as www.totaljobs.com/job/89904527

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