Regulatory Senior Executive

3 weeks ago

Ware, United Kingdom SRG Full time

Job Title: Regulatory Senior Executive Location: Ware or London Contract: 12 Months / Hybrid Hours: 37.5 hours Rates: £448.80 p/d Job Description SRG seeking a highly motivated, self-driven and enthusiastic Regulatory Affairs professional to join a Small Molecules Development Projects CMC Regulatory Affairs Group for a leading pharmaceutical company. As Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) Executive, you will be responsible for managing global acceleration of CMC regulatory marketing applications and early lifecycle activities for multiple projects and teams simultaneously. You will interpret and advise teams on global guidelines, procedures and policies relating to development, registration and manufacture of new pharmaceutical products, responding readily to changing events and priorities. Duties and Responsibilities Driving the CMC strategy for global and regional acceleration submissions to support development/registration/lifecycle maintenance submission content, in accordance with the applicable regulatory & scientific standards and taking account of evolving regulatory requirements. Ensuring all appropriate CMC regulatory submissions are in place, to enable rapid launch and continuity of market supply. Taking accountability for submission content and ensuring information submitted in marketing applications/lifecycle maintenance submissions meets regional requirements, allowing maximum ...

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    Ware, United Kingdom SRG Full time

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