Insuvia is an outsourcing and consultancy services provider for the pharmaceutical industry. We help pharmaceutical & biotech companies make safe and effective healthcare products available worldwide by providing superior quality pharmacovigilance and regulatory affairs services.Dé el siguiente paso en su carrera profesional ahora: desplácese hacia abajo para leer la descripción completa del puesto y envíe su solicitud.We are looking for a Local Regulatory Affairs & Pharmacovigilance Specialist in Spain to join our team on a freelance basis for a long-term partnership. This is a fully remote position; however, residency in Spain and fluency in the Spanish language are required to fulfill the responsibilities.Main Responsibilities:Regulatory Affairs:- Act as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups.- Serve as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements.- Support the preparation and submission of regulatory applications, including new marketing authorisation (MA) applications, variations, renewals, MA transfers, and related correspondence. Submit national declarations and notifications as required.- Compile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio.- Translate and revise product information (e.G., Summary of Product Characteristics, Package Leaflet).- Validate artworks to ensure compliance with the marketing authorisation and local legislation.- Review promotional materials for regulatory compliance.- Advice on launch requirements.- Manage AEMPS portal.- Support with labeling exemptions and consultations regarding orphan medicines supply.- Work within clients' systems.Pharmacovigilance:- Act as the Local Person for Pharmacovigilance (LPPV) nominated for National Competent Authority on behalf of Insuvia Clients.- Serve as the primary contact and subject matter expert for pharmacovigilance advising internal teams and external clients on local regulatory requirements.- Conduct local literature monitoring for pharmacovigilance purposes by reviewing relevant publications in approved sources- Monitor local PV legislation and maintain knowledge of local and European regulatory requirements for pharmacovigilance.- Maintain audit readiness and represent MAH's under responsibility during inspections/audits- Collect ICSRs and other safety data, including proper local management of it and timely delivery to global PV department.- Ensure proper local PV system functioning, including but not limited to adaptation and implementation of additional risk minimisation measures (aRRMs), preparation of PV compliance reports, handling other PV related requestsRequirements:- University degree in medicine, pharmacy, life sciences, or a related field.- Experience in pharmacovigilance and regulatory affairs (minimum 2 years)- Fluent in Spanish and English, both written and spoken.- Strong knowledge of local regulations and requirements.- Experience serving as a local PV contact (LPPV or deputy) in Spain.- Attention to detail- Focused on quality and productivity- Customer-orientedWhy join us- Engaging, dynamic and diverse work in a young and rapidly growing company.- International and multicultural environment.- A workplace where your input matters and has an impact. xhfqzwm - Broad opportunities for self-expression and professional growth.- Remote work