ROLE: Regulatory Compliance Manager (Pharmaceuticals)ESSENTIAL Well-developed regulatory compliance experience in the pharmaceutical industry. At least 6 years of relevant experience in the pharmaceutical industry, with preferably 4 years in compliance in Regulatory Affairs preferably with some Quality Assurance experience Well developed understanding of the medicines manufacturing testing and release Good knowledge of EU directives, ICH guidelines.UK requirements PRIMARY RESPONSIBILITIES Manage the preparation and review of dossiers for MA variation applications, MA renewals and other regulatory post licensing submission in all territories in which Syri/ Syri Pharma holds marketing authorisations and ensures timely submission of applications meeting pre agreed timelines Manage the preparation and review of responses to requests for further information from regulatory authorities for all post approval regulatory submissions. Liaise and follow up with regulatory authorities submissions and regulatory issues. Maintaining the product life cycle once the licence is approved. Responsible for the preparation, maintenance and review of product approval packages. Ensure with internal and external contacts that regulatory dossiers maintained, up to date and in compliance following the current best practice standards. Prepare with SOPs, Change controls and review of internal processes. Creating and monitoring all regulatory changes through change control system.Manage staff assigned to post approval regulatory affairs in the UK.Co-ordinate post approval regulatory activity with regulatory team In IndiaManage and ensure regulatory compliance ensuring manufacturing, testing and release activities and labelling are in compliance with approved registrations at Syri and CMO manufacturing sites. Liaising with CMO sites when required and provide regulatory support to facilitate batch release. Collaborate with internal departments for resolving any regulatory discrepancies. Participate in the regulatory meetings with internal or external clients Co-ordinate and provide regulatory support to the licensing partners in the respective territories for post approval regulatory activitiesMaintaining status oversight on Regulatory-related Deviations & related CAPA assigned to RASupport Audit & Inspection-readiness activities. Collaborate with Audit/Inspection Observations owners and related CAPA owners by providing support to facilitate timely resolution and closure.Participate to compliance's risk mitigation and process improvement initiatives in collaboration with all the concerned parties within and outside RA. Proactively troubleshooting technical/quality issues relating to product preparations and submissions. Provide post approval regulatory support to the other departments. Training of junior members of the Regulatory Department Keeping up-to-date with the current regulations/ guidelines and share the knowledge with the teamOTHER Educated at Bachelor's Degree, Master's Degree or a Ph.D.Regulatory audits and inspections experience is an asset