• Regulatory Affairs Manager Cambridge
  • Proclinical in Cambridge, , United Kingdom
  • jobs
  • 5 days ago

jobs description

Proclinical is seeking a Regulatory Affairs Manager. This role is pivotal in providing country-specific regulatory expertise and execution for the management of biotechnology products. The successful candidate will be responsible for coordinating and carrying out regulatory submissions in compliance with national regulatory requirements as well as the company's business standards. This role also involves supporting and executing local and EU regulatory strategy, including the management of marketing authorisations, clinical trial application submissions and regulatory support for commercial activities.

• Manage regulatory affairs and local regulatory strategy for a portfolio of products.
• Ensure timely regulatory submissions that meet all regulatory requirements.
• Contribute to and execute the filing plan for their country where applicable.
• Represent regulatory on cross-functional brand or project teams and provide advice on local regulatory and compliance...
Cambridge UK


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