Jr Regulatory Affairs Coordinator

hace 3 semanas

Panamá, Panamá Servier Centroamérica Y Caribe A tiempo completo

MAIN RESPONSIBILITY The Jr. Regulatory Affairs Coordinator will be responsible for managing and ensuring compliance with local regulations regarding the registration, renewal, and variation of pharmaceutical products. This role is crucial for ensuring that all products meet regulatory requirements and maintaining effective communication with Competent Authorities.
DETAIL Submission and follow up of new registrations according to define plan and according to products and countries responsibilities. Submission and follow up of renewals, according to define plan and according to products and countries responsibilities. Submission and follow up of variations according to define plan and according to products and countries responsibilities. Update packaging items according to local requirements and according to products responsibility. Organizing and/or coordinating contacts with Competent Authorities (CA).
Review and approved according to the local procedures the promotional material at the subsidiary level according to products distribution.
Improve the performance of our local regulatory contacts (follow up, meetings) Ensuring a regulatory intelligence concerning to local regulations topics belonging according to country responsibilities Ensure the archive of the registration files and update regulatory data bases with the latest information (local and global) To recognize, record and report any potential pharmacovigilance information (such as adverse drug reactions) that the employee is made aware of and in line with Company procedures.
To ensure that all medical enquiries are processed in accordance with the in line with Company procedures.
To ensure all activities are conducted within the framework and full compliance of the internal Company procedures, FEDEFARMA Code of Good Practices and all applicable legislation aimed minimizing the exposure and risk of the Company. To always act in a professional manner, holding compliance to all local regulations and procedures (Global and Local) at the forefront of actions.
Ensure compliance with Servier´s Code of Conduct.
To ensure completion of all training materials provided by Servier to collaborators in a timely manner.
To undertake any other tasks or projects as requested by the line manager.

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