Regulatory Affairs Leader

Job Summary

Manage the submission and approval  of sanitary certificates for new products, renewals, and modifications in the country to  ensuring compliance with sanitary regulations to guarantee marketing and distribution requirements

Job Responsibilities

• Prepare and endorse applications for health license authorization and registration for each of the products distributed and marketed by Apotex, in accordance with the process established by the health authority to facilitate import procedures and avoid delays in the dispatch and release of orders.
• Monitor, report, and promptly communicate to the respective authorities the destruction of product, coordinating with the accounting and warehouse departments the review of supporting documentation for this procedure, to guarantee compliance with the requirements of the health authority.
• Process regulatory documentation for products, coordinating with Regulatory Affairs Mexico, submitting regulatory applications to the National Directorate of Pharmacy and Drugs, and following up on obtaining registrations, certifications, updates, and other requirements to comply with the Health Law. Coordinate the shipment of documentation and samples for registrations, ensuring that the information is complete.
• Purchase and import the standards and samples required for sanitary registration processes, obtaining quotes and confirming purchases from companies that provide this service for sanitary registration and post-registration processes when required.
• Verify that the product commercialized in Panama, meets with the quality standards according to the approved conditions by the MoH
• Release the product for commercialization
• Process authentications, legalizations, endorsements, translations, and certifications, preparing the documentation and submitting it to the corresponding authorities to obtain the necessary documentation to market the products.
• Carry out the necessary procedures for participation in Public Bidding Processes.
• Responsible for pharmacovigilance before the authorities, monitoring reported failures to ensure compliance with the Ministry of Health's requirements, with the following activities:

1. a) Maintain a pharmacovigilance system that allows for the collection and evaluation of information on adverse drug reactions reported to the marketing authorization holder, in order to promptly send it to the Pharmacovigilance Center.
   b) Act as the single point of contact for pharmacovigilance for the national regulatory authority 24 hours a day and also as the point of contact for pharmacovigilance inspection
   c) Fulfill commitments and respond to requests from the Medicines Regulatory Authority, including providing accurate and complete information.
   d) Communicate safety issues between the marketing authorization holder and the competent authorities, particularly notifying changes in the risk-benefit ratio of medicines.

Job Requirements

• Education
  • Bachelor’s degree in Pharmacy
    
    
• Knowledge, Skills and Abilities
  • Knowledge in Microsoft office
  • Good communication with authorities.
  • Good communication in English
  • Strong attention to detail and problem-solving abilities.
    
    
• Experience
  • 3 -5 years of experience in pharmaceutical industry regulatory affairs
  • Advance English