Regulatory Affairs Analyst

Description

Position Summary: We are seeking a Regulatory Affairs Analyst to comprehensively manage registrations with DIGEMID, validate technical documentation, and ensure regulatory compliance. Key Highlights: 1. Comprehensively manage registrations, renewals, and modifications before DIGEMID. 2. Validate technical documentation and monitor the validity of sanitary registrations. 3. Serve as the technical liaison and maintain the documentary archive. This is your opportunity to join our team **REGULATORY AFFAIRS ANALYST** Send your CV to **jdurand@tagacorp.com.pe** **Main Responsibilities:** * Comprehensively manage registration, re-registration, renewal, and modification processes before DIGEMID, including preparation of technical dossiers and tracking of files until final approval. * Verify that technical documentation from domestic and international manufacturers (specifications, labeling, certificates) complies with Peruvian regulations, managing technical translation and resolution of observations raised by the regulatory authority. * Monitor the validity of sanitary registrations and certifications by maintaining databases and issuing timely alerts regarding expirations or regulatory changes that may impact importation or commercialization. * Maintain the technical archive (physical and digital) and ensure information traceability to provide specialized documentary support during inspections, audits, or internal departmental requests. * Act as the technical liaison between suppliers, regulatory authorities, and Logistics, Quality, and Commercial departments, while also performing additional tasks assigned by the Technical Management. **Personal Characteristics (Competencies):** * Effective communication * Organization and planning * Attention to detail * Teamwork * Handling of confidential information * Adaptability * Process follow-up and control **Requirements:** * Degree in Pharmaceutical Chemistry. * Minimum 2–3 years of experience in regulatory affairs (managing procedures before DIGEMID). * Knowledge of sanitary registration management, including registration, re-registration, modifications, renewals, and updates. * Experience reviewing and handling regulatory technical documentation. **Technical Knowledge:** * Current sanitary regulations applicable to medical devices and regulated products in Peru. * Proficiency in the VUCE platform (desirable). * Preparation and review of technical dossiers. * Interpretation of certificates, IFUs, labeling, manufacturer letters, and technical specifications. **Computer Skills:** * Microsoft Office, Teams, Outlook * Document control systems and databases. * Digital document storage and management tools. * ERP or administrative software proficiency (desirable). **Benefits:** * Formal employment contract from day one (General Regime). * Market-competitive salary. * Positive work environment. * Ongoing training opportunities. * Statutory life insurance and other benefits. **Work Location:** La Victoria \- Lima Join our family and grow with us! **\#apply, \#share, \#refer.** Salary: S/.1\.00 per month Application Question(s): * Please describe in detail your experience in this role: * Are you available to start immediately? * What aspects do you consider essential for managing procedures and files before DIGEMID? Please elaborate. * How long would it take you to reach our offices (La Victoria District)? * Please indicate your salary expectation — is it negotiable? Work Location: On-site employment