Regulatory Affairs Assistant

Description

Job Summary: We are seeking a proactive and methodical Regulatory Affairs Assistant to support the collection, organization, and digitization of regulatory documents, and assist in preparing technical files. Key Highlights: 1. Support in the collection and organization of regulatory documents. 2. Assistance in preparing regulatory technical files. 3. Active collaboration in addressing observations raised by authorities. At **PETLABET S.A.C.**, we are searching for top talent to fill the position of **Regulatory Affairs Assistant**, working onsite in the district of Carabayllo. We seek a proactive, methodical candidate with strong organizational skills and a focus on document control and quality to join our team. **Main Responsibilities:** * Support the collection, organization, and digitization of regulatory documents for the department. * Assist in preparing technical files for national and international health registrations and renewals. * Maintain up-to-date and well-organized physical and electronic files for the Regulatory Affairs department, ensuring traceability of technical data sheets and safety data sheets (SDS). * Provide basic support in reviewing labeling and packaging materials according to established regulatory guidelines. * Conduct bibliographic and current regulatory research as directed by the Regulatory Affairs team. * Coordinate the logistical flow of shipment and receipt of samples related to official regulatory procedures. * Support preparation of progress reports on regulatory procedures submitted to authorities and adherence to registration timelines. * Actively collaborate in responding to and resolving minor observations issued by competent authorities. * Maintain smooth communication with other internal departments such as Quality Control, Production, and Design to provide technical or documentary information upon request. * Participate in internal training and capacity-building sessions to strengthen competencies in the regulatory field. * Support the assembly, pagination, and structuring of technical dossiers, ensuring complete compilation of required legal, commercial, and quality documentation for submissions to health authorities. **Minimum Requirements:** * Completed or final-cycle technical or university studies in Pharmacy and Biochemistry, Pharmaceutical Chemistry, Veterinary Medicine, or related fields. * Minimum desirable experience of 6 months to 1 year performing administrative support, document control, or internships in Regulatory Affairs, Quality Assurance, Technical Archives, or related areas. * Proficiency in computer tools (MS Office / Google Drive / Excel) at an intermediate user level (e.g., organizing folders in cloud storage). * Immediate availability to work 100% onsite in the district of Carabayllo. **Benefits and Working Conditions:** * Base salary: S/. 2,500\.00 – S/. 3,000\.00 per month, subject to evaluation of certified experience. * Full payroll enrollment from day one, including all statutory benefits (bonuses, CTS, vacation, ESSALUD, family allowance as stipulated by law). * Direct employment contract with the company. * Fixed working hours: Monday to Friday, 8:00 a.m. to 5:00 p.m.; Saturdays, 8:00 a.m. to 12:00 p.m. Salary: S/.2,500\.00 \- S/.3,000\.00 per month Work Location: Onsite employment