ppAt Auren Personas we work from the Recruitment Executive Search division and we are dedicated to providing specialized Human Resources consulting services. /p h3About the role /h3 pSupervise 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. /p h3Duties /h3 ul liAssist 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). /li liEnsure regulations compliance (on both European and local regulations) for all Cipla products. /li lieCTD compilation /li liCollect and evaluate scientific data. /li liPrepare labelling, PIL, SmPC and mockups of medicinal products, and adaptation to current QRDs. /li liProvide strategic advice throughout the development of new products. /li liManaging teams of colleagues involved with the development of new dossiers. /li liKeeping abreast of international legislation, guidelines,



and customer practices in all countries that the company is working. /li liAdvise clients and manufacturers on regulatory requirements. /li liWork with specialist computer software and resources (eCTDmanager, Lorenz Validator, RAEFAR, etc). /li liNegotiate 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. /li liSubmit price reimbursements procedures for the new products including negotiations with the MOH /li liSupport the quality team in the local release of the products /li liAct as the point of contact for the Pharmacovigilance department, being the local QPPV /li /ul h3Requirements /h3 ul liAt least 3 years in a similar work position. /li liB. sc degree in life science (Chemistry, Biology, Pharmacy, etc). /li liMaster or related course in Regulatory Affairs will be desirable. /li liEnglish level: High (spoken and written). /li liProfessional development opportunities in an international environment. /li liPartial remote work options. /li /ul /p #J-18808-Ljbffr

📌 REGULATORY AFFAIRS AND LOCAL QPPV(Embedded Solution) (Madrid)
🏢 Auren Personas - Selección & Executive Search
📍 Madrid