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Immediate opening for an experienced Regulatory Affairs Manager to join this global CRO.
Due to an increase in workload our client is looking for a Regulatory Affairs Manager to be based in their office in Cambridge. You will be responsible for providing timely, accurate regulatory advice on strategy and will manage projects in the provision of regulatory affairs services. This will involve you liaising with internal and external clients in the provision and marketing of these services.
A key aspect of your role will be to take primary Regulatory responsibility for effective interactions with the Authorities to support local/central functions and assigned activities. You will also be expected to build and maintain local, central and external relationships in order to influence the regulatory environment, particularly those within Europe.
Responsibilities:
• Provide project specific regulatory services and co-ordination of projects.
• Review and assist in preparing regulatory submissions in Europe.
• Build and maintain local, central and external relationships in order to influence the regulatory environment.
• Effective interaction with authorities to support local/central functions and assigned activities.
• Effective communication/reporting on assigned activities.
• Provide input to regulatory strategy and product development advice.
• Contribute to development and implementation of Global/European Regulatory function/plans.
• Ensure quality and compliance with local and EU legislation.
• Provide regulatory advice and training for regulatory affairs in the company.
• Manage other local regulatory affairs individuals as necessary.
• Assist in local business development and pricing of projects for Regulatory Affairs in the company.
Additional:
• Provide a regulatory intelligence service to the organisation with respect to French regulatory and associated requirements.
• Lead and train a small group of regulatory professional and/or regulatory consultants as required depending on business need.
• Assist in budgeting as necessary.
You will have experience in a broad range of Regulatory Affairs issues gained within the CRO or Pharmaceutical industry. Extensive knowledge of regulatory applications and procedures, especially those related to clinical trials, along with proven success in agency influencing and negotiation, would be an advantage.
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