Regulatory Affairs Senior Associate

SRG Clinical ,
London, Greater London
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Overview

My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team and is looking to recruit a Senior Regulatory Affairs Associate on an initial 12 month contract to be based in their offices in Middlesex. The Role: The Regulatory Professional under the direction of a Regional Regulatory Lead will assist in the creation and submission of regulatory documents and may be the regulatory lead for a program under the supervision of a more experienced regulatory lead. Key Responsibilities: Assist Regional Regulatory Lead to support regional regulatory pre-filing activities (e.g. core CTA/IMPD development and submission, support for pre-MAA filing) Provide and maintain CTA/MA documentation support (e.g. variations, substantial amendments, PDCO annual reports) in collaboration with Regional Regulatory Lead Create and maintain product regulatory history documents through IMR/rRISE and appropriately archive all regulatory documents and agency communications Review regional component of the Global Regulatory Plan and provide input to operational deliverables Ensure compliance via timely submissions to regulatory agencies and support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CROs / partners to support site initiation and coordinate collection of functional documents in support of regulatory applications As appropriate participate in GRT to support execution of regulatory strategy and coordinate QC of regulatory documentation (e.g. briefing packages) Provide primary authorship to routine regulatory correspondence (e.g. annual reports, investigator packages) Prepare regulatory packages and cross-reference letters to support investigator initiated studies Approve drug shipment for Amgen and Investigator Initiated Studies Complete regulatory forms to support agency communications (E.G. EudraCT,) Support process improvement initiatives, standards development, and metrics Skills/Experience Required: Minimum graduate level, in any life sciences. EU experience, regional level rather than affiliate level Preparing and submitting CTAs applications. It would be a bonus if they have used the VHP. Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products. 3 years' experience If you are interested in this role or would like to have a confidential discussion regarding other Regulatory Opportunities. Please contact me: or 01753 589673 This job was originally posted as www.totaljobs.com/job/89829462

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