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CK Group
,
London, Greater London
Regulatory Professional
Overview
CK Group are recruiting for a Regulatory Professional to join a company in the Pharmaceutical industry at their site based in Uxbridge on a contract basis for 12 months and has a hourly rate of £23.85 PAYE. The Company: Our client is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Our client has been a biotechnology pioneer since 1980. They have grown to be one of the world's leading independent biotechnology companies, reaching millions of patients around the world. Currently they are developing a pipeline of medicines with breakaway potential. The Location: Our client is situated about 3 km to the north of the historic and picturesque city of Cambridge. This location is easily accessible by car, train or by bus. 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, regulatory authority meeting preparations). - 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 Support RRL in review of promotional materials for commercial activities (ex-US) Collaborate with CROs/partners to support site initiation. - Coordinate collection of functional documents in support of regulatory applications. Your Background: - EU experience, regional level rather than affiliate level. - Preparing and submitting CTAs applications. It would be a bonus if they have used the VHP. Coordinating response preparation. - Assisting in the preparation of post authorisation submissions. For example, variation applications, RTQs for centrally authorised products, or purely national products. - Should be confident writing cover letters, application forms and help/assist in pulling together responses with the support of a cross-functional team. - Must have a scientific background. - Good written and spoken ability. - Excellent attention to detail. - Some familiarity with regulatory guideline. For more information or to apply for this Regulatory Professional position, please contact CK Group, quoting job ref 47972. It is essential that applicants hold entitlement to work in the UK.