Regulatory Affairs Assistant - Laboratory

Description

Position Summary: A leading pharmaceutical company is seeking a Regulatory Affairs Assistant to prepare, review, and organize veterinary product registration dossiers and monitor regulatory procedures. Key Highlights: 1. Experience in regulatory affairs and sanitary regulations. 2. Preparation and follow-up of veterinary product registration dossiers. 3. Support in BPM implementation and maintenance processes. A prominent pharmaceutical company is currently seeking a Regulatory Affairs Assistant to join our team. **Requirements:** 1\. Bachelor's degree or graduate in Veterinary Medicine, Pharmaceutical Chemistry, Animal Science Engineering, or related fields. 2\. 6 months to 1 year of experience in regulatory affairs. 3\. Knowledge of sanitary regulations and legal text review. 4\. Proficiency in computer tools and control matrices. 5\. Specialization or training courses in regulatory affairs, quality, or BPM are desirable. **Responsibilities:** 1\. Prepare, review, and organize veterinary product registration dossiers. 2\. Monitor regulatory procedures before SENASA. 3\. Review technical documentation from domestic and international manufacturers. 4\. Coordinate with suppliers to request: \- Certificates of Analysis (COA), \- specifications, \- analytical methods, \- validations, \- GMP/BPM certificates, \- supplementary technical documentation. 5\. Support BPM implementation and maintenance processes. 6\. Maintain the regulatory documentation database up to date. 7\. Draft responses to regulatory observations. 8\. Coordinate with Quality, Import, Production, and Commercial departments. 9\. Track regulatory expiration dates and renewals. **Benefits:** 1\. Competitive salary aligned with the labor market. 2\. Working hours: Monday to Friday. 3\. Pleasant work environment. Salary: S/.1\.00 \- S/.2\.00 per month Application Question(s): * What are your salary expectations? Work Location: On-site employment