Regulatory Affairs (RIMS)
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A highly self-motivated and adaptable BSc Hons Biomedical Science graduate (2.1) actively seeking an associate level role within regulatory affairs. Possesses two years regulatory affairs experience in generic human medicinal products and medical devices with two years complementary experience in community pharmacy as a NVQ Lvl 2 pharmacy dispenser. Achieved a good understanding of the drug development process, CTD structure (modules 1-5) and regulatory submission pathways (Type IA and IB) when completing the TOPRA essentials of European pharmaceutical regulatory affairs course.
Gained valuable regulatory affairs experience when preparing variation packages for type IA and IB submissions to MHRA (Cesp and Nees formats), Initiating change controls, writing an SOP on EUDAMED data collation and creating a process map for this. Also updated product license files and specifications (DSSM, IPSM and FPSM) post variation approval for regular implementation on API testing, batch release and manufacturing. Developed excellent cross functional team working skills at Randstad (compliance officer) to achieve a business profit of £1,000,000 and a personal bonus for 2021.
Looking settle into a long-term career in regulatory affairs with aims of advancing to a senior regulatory affairs associate while enhancing on current knowledge and skills.
Please view my CV for further details on my professional experience.
BSc Hons Bionedical Science (IBMS Accredited - Grade 2.1)