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Regulatory Affairs Associate- 12 month, freelance contract, Office based -
Uxbridge. Pay rate - £18.12 per hour Overview;
The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents mostly related to clinical trials in the EU. Over time the scope could expand to also support other regulatory activities like post-approval variations, annual reports, pre-MAA filing or regulatory authority meeting preparations.
Responsibilities; In collaboration with Regional Regulatory Lead create and maintain product regulatory history documents and appropriately archive all regulatory documents and agency communications. Ensure compliance via timely submissions to regulatory agencies. Coordinate collection of functional documents in support of regulatory applications. Coordinate QC of regulatory documentation (e.g briefing packages). Prepare regulatory packages and cross-reference letters to support investigator initiated studies. Complete regulatory forms to support agency communications (e.g. EudraCT). Support process improvement initiatives, standards development, and metrics. Assist in template development and maintenance. Actively support regulatory compliance.
Key Skills: Good communication skills - oral and written. Organizational skills. Understanding of drug development process. Minimum of one year experience in Regulatory Affairs in the pharmaceutical industry. Applicants must have exposure to CTA's
This role will be paying £18.12 per hour under an umbrella basis based on a 37.5 hour week on a 12 month project. Great role for someone with 6-12 month experienced. If you would like to hear more please contact Vik Patel at ARM on 02392 458031 or email me on firstname.lastname@example.org
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