Role Overview We are seeking an experienced Regulatory Affairs Officer to join our Regulatory Affairs team.ResponsibilitiesLead and coordinate the preparation and submission of applications for marketing authorizations in Switzerland.Manage the maintenance of existing marketing authorizations for assigned products, including handling indication or text changes, technical modifications, commitments, and renewals.Provide support for applications, variations, and renewals in export (MENA) markets, collaborating closely with the local team.Develop regulatory strategies for CMC changes, product acquisitions, and due diligence activities.Perform regulatory assessments and manage any resulting regulatory actions in response to change control requests.Stay abreast of CH and EU pharmaceutical regulations, ensuring compliance and alignment with evolving regulatory requirements.Develop and maintain internal regulatory SOPs, databases, and IT tools to streamline regulatory processes.Collaborate with other departments, including Medical Information and Pharmacovigilance, to support regulatory activities and ensure regulatory compliance across the organization.Provide support for the review and approval of promotional materials in Switzerland, as needed.QualificationsMaster's degree in pharmacy or equivalent Life Science.Minimum of 5 years of relevant experience in the EU or CH regulatory pharmaceutical environment.Experience in CMC and Labelling.Experience in preparation and submission of eCTD (e-publishing and e-submission system).Fluent in English (verbal and written).French is a strong asset.BenefitsA collaborative and friendly environment within a human-size company.An established company operating with agility.Continuous professional training to develop your potential.Rewarding compensation & benefits package.About the Company Labatec is a Swiss-based private pharmaceutical company headquartered in Geneva, Switzerland. We specialize in producing and supplying medicines to more than 11 countries, and we are expanding across Europe. Our focus includes generic and specialty innovative medicines, with a portfolio of 70+ products across the retail and hospital sectors.#J-18808-Ljbffr