Description
Position Summary:
We are seeking a Pharmaceutical Chemist to serve as Technical Director with experience in Regulatory Affairs, Good Storage Practices (GSP), Good Distribution and Transportation Practices (GDP&T), and sanitary management in pharmaceuticals and/or medical devices.
Key Highlights:
1. Experience in Regulatory Affairs, GSP, and GDP&T
2. Management of regulatory procedures and sanitary registrations
3. Representation before DIGEMID and regulatory authorities
**Full Job Description**
We are seeking a Pharmaceutical Chemist to serve as Technical Director, with experience in Regulatory Affairs, GSP, GDP&T, and sanitary management in the pharmaceutical and/or medical device sector.
Requirements:
* Professional degree in Pharmaceutical Chemistry, registered and licensed in Peru.
* Minimum of 2 years’ experience in pharmaceutical pharmacies.
* Knowledge of DIGEMID regulations, Good Storage Practices (GSP), Good Distribution and Transportation Practices (GDP&T), and regulatory documentation for pharmaceutical products.
* Experience in procedures and compliance with sanitary authorities.
* Experience in managing sanitary registrations (new, modifications, and re-registrations) is preferred.
* Knowledge and experience in submitting major change applications to DIGEMID.
* Proficiency in computer tools and document management systems.
* Responsible, proactive profile with strong commitment to regulatory compliance.
* Immediate availability for full-time employment.
Main Responsibilities:
* Exercise Technical Direction and represent the company before DIGEMID and other regulatory authorities.
* Supervise and ensure compliance with Good Storage and Transportation Practices.
* Manage and maintain up-to-date technical, legal, and sanitary documentation of the establishment.
* Handle regulatory procedures, sanitary registrations, re-registrations, and modifications before DIGEMID.
* Control and guarantee traceability, safety, and quality of marketed products.
* Ensure strict compliance with sanitary regulations across all technical activities of the company.
Employment Type: Full-time
Salary: S/.2,300.00 \- S/.3,500.00 per month
Work Location: On-site employment