Regulatory Affairs Assistant - Veterinary

Description

Position Summary: A leading pharmaceutical company is seeking a Regulatory Affairs Assistant to prepare, review, and organize veterinary product registration dossiers and follow up on regulatory procedures. Key Responsibilities: 1. Preparation and review of veterinary product registration dossiers 2. Regulatory procedure follow-up with SENASA 3. Coordination with suppliers and internal departments A leading pharmaceutical company is currently seeking a Regulatory Affairs Assistant to join our team. **Requirements:** 1\. Bachelor's degree or graduate in Veterinary Medicine, 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 IT tools and control matrices. 5\. Regulatory affairs, quality, or GMP/BPM specialization or training is desirable. **Responsibilities:** 1\. Prepare, review, and organize veterinary product registration dossiers. 2\. Follow up on regulatory procedures with 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\. Monitor regulatory expiration dates and renewals. **Benefits:** 1\. Competitive market-based salary 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