Regulatory Affairs Assistant - Laboratory

Description

Position Summary: A leading pharmaceutical company is seeking a Regulatory Affairs Assistant to prepare, review, and organize 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 and coordination with suppliers. 3. Support in BPM implementation and maintenance of the regulatory documentation database. 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\. Follow up on regulatory procedures with SENASA. 3\. Review technical documentation from domestic and international manufacturers. 4\. Coordinate with suppliers for requests of: \- Certificate 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 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