PAt bAuren Personas /b we work from the Recruitment Executive Search division and we are dedicated to providing specialized Human Resources consulting services. /ppWe 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. /ppbr/ppbAbout the role: /b /ppSupervise and coordinate the execution of formulation, manufacture, dossier construction, registration of products. Also supervise the registration of companies, where applicable. Act as the local QPPV /ppbr/ppbDuties required: /b /pulliAssist 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). /liliEnsure regulations compliance (on both European and local regulations) for all Cipla products. /lilieCTD compilation /liliCollect and evaluate scientific data. /liliPrepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs. /liliProvide strategic advice throughout the development of new products. /liliManaging teams of colleagues involved with the development of new dossiers. /liliKeeping abreast of international legislation, guidelines, and customer practices in all countries that the company is working. /liliAdvise clients and manufacturers on regulatory requirements. /liliWork with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc). /liliNegotiate 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. /liliSubmit price reimbursements procedures for the new products including negotiations with the MOH /liliSupport the quality team in the local release of the products /liliAct as the point of contact for the Pharmacovigilance department, being the local QPPV /li /ulpbr/ppbRequirements /b: /pulliAt least 3 years in a similar work position. /liliB. sc degree in life science (Chemistry, Biology, Pharmacy, etc). /liliMaster or related course in Regulatory Affairs will be desirable. /liliEnglish level: High (spoken and written). /li /ulpbr/ppbr/ppbBenefits: /b /pulliProfessional development opportunities in an international environment /liliPartial remote work options. /li /ulpbr/ppbr/ppWe appreciate your application and interest, we look forward to meeting your talent! /ppAt Auren Selección Executive Search, we offer a global range of solutions for the identification, recruitment, selection and evaluation of talent. /ppWe provide local and international services for any volume. We have highly specialized teams, more than 20 years of experience and proven success stories. /p