Senior Regulatory Conformance Officer – West Sussex – £35/hr

Senior Regulatory Conformance Officer – West Sussex – 12-month contract – £35/hr

About the company:

My client is an emerging, small pharmaceutical company with global ambitions. As part of a growing team, you can expect early responsibility and team leadership within the division by the end of your contract. Although this is a contract position, my client has made a strong indication that this will become a permanent position upon successful completion of the project at hand.

Your role:

- Develop and maintain a thorough knowledge of the regulatory environment in relation to marketing and clinical trial authorisations in the UK and Europe.
- Understand the commercial environment in the UK.
- Provide regulatory guidance during development to support life cycle management.
- Critically review, prepare or manage the preparation of high quality documents for submission to relevant regulatory authorities.
- Provide responses to questions relating to the submission of regulatory documents.
- Review patient information leaflets and summary of product characteristics to ensure compliance with current legislation.
- Establish and maintain relationships with regulatory authorities both internally and externally.
- Work with supply chain personnel to agree regulatory strategy.

Experience:

- As an ideal candidate, you will have 2 year’s experience within the pharmaceutical industry.
– You will have some familiarity with pharmaceutical R&D processes.
– You will be able to critically review and integrate information from different disciplines.
– You will have good administrative skills.
– You will have excellent attention to detail and written and oral communication skills.

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