PInsuvia 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. /p pWe are looking for a bLocal Regulatory Affairs Pharmacovigilance Specialist in Spain /b to join our team on a bfreelance /bbasis 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. /p pbMain Responsibilities /b: /p pRegulatory Affairs: /pulliAct as the local Regulatory Affairs representative; communicate with regulatory authorities regarding pre-submission strategies, regulatory pathways, compliance requirements, and submission follow-ups. /liliServe as the primary contact and subject matter expert for regulatory affairs, advising internal teams and external clients on local regulatory requirements. /liliSupport 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. /liliCompile and maintain regulatory documentation and databases, track life-cycle submissions, and oversee regulatory duties for the assigned product portfolio. /liliTranslate and revise product information (e.g., Summary of Product Characteristics, Package Leaflet). /liliValidate artworks to ensure compliance with the marketing authorisation and local legislation. /liliReview promotional materials for regulatory compliance. /liliAdvice on launch requirements. /liliManage AEMPS portal. /liliSupport with labeling exemptions and consultations regarding orphan medicines supply. /liliWork within clients’ systems. /li /ul pPharmacovigilance: /pulliAct as the Local Person for Pharmacovigilance (LPPV) nominated for National Competent Authority on behalf of Insuvia Clients. /liliServe as the primary contact and subject matter expert for pharmacovigilance advising internal teams and external clients on local regulatory requirements. /liliConduct local literature monitoring for pharmacovigilance purposes by reviewing relevant publications in approved sources /liliMonitor local PV legislation and maintain knowledge of local and European regulatory requirements for pharmacovigilance. /liliMaintain audit readiness and represent MAH’s under responsibility during inspections/audits /liliCollect ICSRs and other safety data, including proper local management of it and timely delivery to global PV department. /liliEnsure 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 requests /li /ul pbRequirements: /b /pulliUniversity degree in medicine, pharmacy, life sciences, or a related field. /liliExperience in pharmacovigilance and regulatory affairs (minimum 2 years) /liliFluent in Spanish and English, both written and spoken. /liliStrong knowledge of local regulations and requirements. /liliExperience serving as a local PV contact (LPPV or deputy) in Spain. /liliAttention to detail /liliFocused on quality and productivity /liliCustomer-oriented /li /ul pbWhy join us /b /pulliEngaging, dynamic and diverse work in a young and rapidly growing company. /liliInternational and multicultural environment. /liliA workplace where your input matters and has an impact. /liliBroad opportunities for self-expression and professional growth. /liliRemote work /li /ul