Manager, Regulatory Affairs Submission Management
Manager - Regulatory Affairs Submission ManagementContract: Temporary - 12 months (extension possible) Location: Maidenhead - hybrid working (or remote if needed) Rate: (INSIDE IR35) - circa. 22-25 per hour (PAYE) SRG are seeking a Regulatory Affairs professional with Submission Management skills and experience to assist a leading pharmaceutical company on a temporary basis. Join a dynamic regulatory affairs team and play a pivotal role in delivering complex regulatory submissions that support the development, approval, and life-cycle management of innovative healthcare products.Key ResponsibilitiesLead and manage complex regulatory submission projects, ensuring high-quality dossiers are delivered on time and in line with regulatory requirements.Act as the primary regulatory submission management contact for cross-functional project teams, providing guidance on processes, timelines, and deliverables.Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.Skills and Experience RequiredBachelor''s degree or equivalent combination of education and relevant ..... full job details .....
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