The position will be responsible for coordination of the compilation and maintenance of regulatory submissions and communication with regulatory authorities in the UK/Europe and US for all issues associated with the company’s expanding drug development pipeline.

The individual selected will be responsible for establishing the necessary structure if it decides to commercialise its products in an international arena.

Principal Accountabilities:

· Provide direction on the compan Regulatory direction

· Monitor regulatory developments in the Renal field and in any other activities the company embarks on

· Ensure the company’s developments meet the necessary guidelines and clinical trials are designed to meet these needs

· Ensure that the work undertaken internally by the company is compliant and to manage the regulatory department.

· Review (where appropriate also write) all documentation required for regulatory submissions and ensure compliance with those submissions

· Manage any interface with the appropriate Regulatory authorities and parties appointed to support the company’s regulatory activities.

· Provide direction and oversight of pharmacovigilance activities to ensure they comply with relevant regulations and are consistent with any regulatory submission strategy.

· Provide reports required by the appropriate authorities from time to time

· Develop a regulatory affairs department and documentation commensurate with the company’s requirements.

· Liaise and manage with any third parties or regulatory house selected to provide external guidance and develop the necessary systems to ensure they are compliant.

· Help develop the appropriate systems to meet the changing submission and GCP control requirements e.g. eCTD

Qualification

- Minimum life science degree

- Minimum 5 year similar role in industry

- Thorough knowledge of European and USA regulations

- Excellent understanding of the drug development process

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