Descripción de la oferta
At Auren Personas we work from the Recruitment & Executive Search division and we are dedicated to providing specialized Human Resources consulting services.Obtenga más información sobre este puesto leyendo los detalles a continuación y luego envíe su solicitud para ser considerado.We are currently collaborating with a leading Pharmacy industry company based in Madrid, which is looking to add a Regulatory Affairs and Local QPPV to its team.About the role:Supervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Act as the local QPPVDuties required:Assist on products registration (human medicines, medical devices, cosmetics, food supplements, etc), variations, renewals, or any other activity regarding the maintenance of the dossiers (e.g., readability tests). These procedures could be National or European procedures (Centralized, Decentralized and Mutual Recognition Procedures).Ensure regulations compliance (on both European and local regulations) for all Cipla products.eCTD compilationCollect and evaluate scientific data.Prepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs.Provide strategic advice throughout the development of new products.Managing teams of colleagues involved with the development of new dossiers.Keeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working.Advise clients and manufacturers on regulatory requirements.Work with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc).Negotiate with regulatory authorities for marketing authorisation, variations, or any other required activity for the approval of client's medicinal products in Spain and other countries, as needed.Submit price & reimbursements procedures for the new products including negotiations with the MOHSupport the quality team in the local release of the productsAct as the point of contact for the Pharmacovigilance department, being the local QPPVRequirements:At least 3 years in a similar work position.B. sc degree in life science (Chemistry, Biology, Pharmacy, etc).Master or related course in Regulatory Affairs will be desirable.English level: High (spoken and written).Benefits:Professional development opportunities in an international environmentPartial remote work options.We appreciate your application and interest, we look forward to meeting your talent!At Auren Selección & Executive Search, we offer a global range of solutions for the identification, recruitment, selection and evaluation of talent.We provide local and international services for any volume. xkdbapo We have highly specialized teams, more than 20 years of experience and proven success stories.
