Senior Regulatory Affairs Specialist

Regulatory Affairs Specialist (Project-Based / Outsource Support)CoSteps ConsultancyCoSteps Consultancy provides regulatory support in pharmaceuticals, cosmetics, medical devices, biocides and food supplements. We are currently looking for an experienced Project-Based Regulatory Affairs Specialist to support our client’s regulatory department on a project / outsource basis.This is not a full-time position. The specialist will contribute to clearly defined work packages within specific projects.ResponsibilitiesManaging project-based regulatory and licensing processes for human medicinal productsSupporting regulatory submissions and approval processes for OTC productsPreparing CTD-format dossiers, submitting to the Authority, and tracking approvalsPreparing and updating SmPC, PIL, and labeling componentsPreparing and following up Type I and Type II variation submissionsSupporting renewal and transfer proceduresArchiving project-related documentation and maintaining databasesSupporting regulatory processes for medical device productsQualificationsDegree in Pharmacy, Chemistry, Chemical Engineering, Biology or related fieldsMinimum 2–3 years of experience in pharmaceutical, OTC and/or medical device regulatory affairsAbility to work independently & deliver project-based responsibilitiesStrong analytical and solution-oriented mindsetProficiency in MS OfficeExcellent command of EnglishWorking ModelProject-based / outsourced collaborationScope, timeline and deliverables will be clarified prior to each projectRemote work is acceptableApplicationProfessionals interested in providing project-based regulatory support may share their CVs with us.