Regulatory Affairs Leader

Apotex•Panama City, FL

38d

About The Position

Manage the submission and approval of sanitary certificates for new products, renewals, and modifications in the country, ensuring compliance with sanitary regulations and marketing and distribution requirements. The Regulatory Affairs Leader prepares and endorses health license authorization and registration applications for products distributed and marketed by Apotex. The role coordinates regulatory documentation and applications with Regulatory Affairs Mexico and the National Directorate of Pharmacy and Drugs, follows up on registrations and related requirements, and coordinates the shipment of documentation and samples. It also purchases and imports standards and samples required for registration processes, verifies product quality against conditions approved by the Ministry of Health, releases products for commercialization, and handles document authentications, legalizations, endorsements, translations, and certifications. The role carries out procedures for public bidding processes and is responsible for pharmacovigilance before the authorities, including maintaining a pharmacovigilance system, serving as the regulatory authority’s 24-hour point of contact, fulfilling authority commitments and information requests, and communicating medicine safety issues and changes in risk-benefit ratios.

Requirements

Bachelor’s degree in Pharmacy.
Knowledge of Microsoft Office.
Good communication with authorities.
Good communication in English.
Advanced English.
Strong attention to detail and problem-solving abilities.
3–5 years of experience in pharmaceutical industry regulatory affairs.

Responsibilities

Prepare and endorse applications for health license authorization and product registration in accordance with health authority processes, facilitating imports and avoiding delays in order dispatch and release.
Monitor, report, and promptly communicate product destruction to the relevant authorities; coordinate with accounting and warehouse departments to review supporting documentation.
Process product regulatory documentation in coordination with Regulatory Affairs Mexico; submit applications to the National Directorate of Pharmacy and Drugs and follow up on registrations, certifications, updates, and other Health Law requirements.
Coordinate shipment of registration documentation and samples, ensuring the information is complete.
Purchase and import standards and samples required for sanitary registration processes, obtaining quotes and confirming purchases with service providers as needed for registration and post-registration processes.
Verify that products commercialized in Panama meet quality standards and conditions approved by the Ministry of Health.
Release products for commercialization.
Prepare and submit documentation for authentications, legalizations, endorsements, translations, and certifications to the relevant authorities.
Carry out procedures required for participation in public bidding processes.
Maintain a pharmacovigilance system to collect and evaluate adverse drug reaction information reported to the marketing authorization holder and promptly send it to the Pharmacovigilance Center.
Act as the single pharmacovigilance contact for the national regulatory authority 24 hours a day and as the point of contact for pharmacovigilance inspections.
Fulfill commitments and respond to requests from the Medicines Regulatory Authority, providing accurate and complete information.
Communicate medicine safety issues between the marketing authorization holder and competent authorities, particularly changes in medicines’ risk-benefit ratios.