Job Description

Accountabilities: As a Regulatory Affairs Manager, you willIdentify regulatory strategies to support commercial and business objectives and company efficiencies. Plan and execute workload for the defined product responsibilities and agreeing plan with Regulatory Affairs LeadProactively manage the regulatory process and effectively negotiate with regulatory agencies to provide rapid regulatory approvals with competitive labellingPrepare high quality regulatory applications and regulatory responses for UK (including inputting into summary documents and responses for European applications)Provide regulatory input to commercial, medical affairs, market access, medical information, patient safety and supply chain functions.Ensure timely submission and approvals of licence applications and maintenance activities and compliance with UK regulatory requirementsAssure appropriate standards and policies for all technical aspects of the company’s activities in Regulatory Affairs are adhered toProvide regulatory input/solutions to supply and stock issuesLiaise with Operations to manage pack changes and ensure labelling complianceEnsure appropriate Regulatory Affairs input into the promotional copy approval process, to ensure that core claims and Prescribing Information are in accordance with the licence