Regulatory Affairs Associate (Graduate)

Job Title: Regulatory Affairs GraduateJob Type: 12 Months Fixed Term ContractEmployment Start Date: ASAPHours of work: Mon - Fri (37.5 hours a week)Onsite requirement: This will be a hybrid role, with at least 3 days per week on siteIndustry: PharmaceuticalsLocation: Bracknell, UKSalary: 30.000 per annum; holidays, sick pay, pension An excellent opportunity for a talented graduate to start a career in regulatory affairs with a global healthcare organisation, our client is a market leader specialising in the development of generic and biosimilar medicines. Job PurposeThis role supports pre- and post-approval regulatory activities to ensure compliance while meeting business needs. Responsibilities include regulatory submissions, labelling and SmPC updates, stakeholder communication, audit support, archive maintenance, and monitoring departmental projects in line with KPIs, while adhering to global and local SOPs and working instructions. Your responsibilities will include, but are not limited to:Preparation and submission of the following: Marketing Authorisation variation and renewal applicationsLabelling update applications under Article 61(3)Change of ownership applicationsLicence cancellationsCreation, assessment and approval of labelling artwork texts and mock-ups.Reviewing and updating Summaries of Product Characteristics.The processing and clear communication of regulatory approvals to internal and external stakeholders.Monitoring and supporting departmental projects in ..... full job details .....