Regulatory Affairs Executive
Regulatory Affairs Executive - Pharmaceuticals - Manchester Smart4 Sciences is partnering with a growing pharmaceutical group to recruit a Regulatory Affairs Executive to support and manage a diverse portfolio of UK licences across parallel import, licensing, and manufacturing operations. This is an excellent opportunity for a regulatory professional with strong MHRA exposure who enjoys ownership, problem-solving, and cross-functional collaboration within a fast-moving pharmaceutical environment. The Role As Regulatory Affairs Executive, you will manage a portfolio of licences end-to-end, ensuring compliant, high-quality submissions to the MHRA while acting as a subject-matter expert for complex licensing scenarios. You will also deputise for the Senior Regulatory Officer when required. Key focus areas include PLPI applications, variations, renewals, and ongoing regulatory compliance across multiple business units. Key ResponsibilitiesManage and maintain your own portfolio of UK pharmaceutical licencesPrepare, submit, and manage PLPI licence applications, variations, and renewalsAct as a key point of contact with the MHRA, proactively resolving RFIs and clarifying requirementsEnsure submissions are approved first time or with a maximum of one RFIMaintain accurate regulatory records and updates within internal systemsSupport buyers and internal stakeholders with up-to-date regulatory guidanceIdentify regulatory changes and assess business impactLead or contribute to ..... full job details .....
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