Job Ref: 215819764

Date: 2022-02-15 14:45:13

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CK Group are recruiting for Regulatory Affairs Manager to join a company in the Pharmaceutical industry at their site based in High Wycombe on a contract basis for 6 months.

Salary:
£64.51 (PAYE) / £88.89 (Umbrella) per hour Depending on experience

Regulatory Affairs Manager Role:
• Participates in the Global Regulatory Team (GRT) and may participate in the Compound Development Team (CDT) if requested.
• Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional climates
• Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments
• Act as primary contact with EMEA. Work through LOC and/or CRO for National Regulatory Agencies contacts, as appropriate
• 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

Your Background:
• Knowledge of the regulatory environment, guidelines and practice of EMEA regions;
• An understanding of competitors in the area and what they did/are doing in early and late development in assigned therapeutic areas and knowledge of labeling aspects;
• Understanding the impact of a new law, guidance or ruling on drug development
• University degree medical paramedical (pharmacy, biology, veterinary etc) or equivalent
• Project Management skills

Company:
Our client is one of the world's leading research-based pharmaceutical companies and is part of a global family of companies.

Location:
This Regulatory Affairs Manager role will be based at our client’s site in High Wycombe, Buckinghamshire although there could be flexibility for home working.

Apply:
For more information, or to apply for this QC Chemist position please contact the Key Accounts Team on (phone number removed) or email (url removed). Please quote reference 52932.
It is essential that applicants hold entitlement to work in the UK

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