07 ene
Takeda Pharmaceutical
Xico
.
**Regulatory Affairs Coordinator**- English version_**WHAT YOU WILL DO**This position will be coordinate the activities derived from the Regulatory Affairs Managers to comply with and monitor the strategy and regulatory plan in accordance with the company's objectives.This role reports to the Regulatory Affairs Manager and is based in México City, México.
**WHAT YOU WILL WORK ON**- Actively work with the Regulatory Affairs Manager to ensure planning, monitoring, alignment and compliance with regulatory deadlines.- Integrate the legal, clinical and technical documentation for the regulatory files of new products, post-authorization commitments and compliance with the life cycle (variations and renewals) of the products,
in collaboration with the global regulatory leaders and with the local multidisciplinary team.- Evaluate global control changes in compliance with local legislation and corporate policies.- Manage local control chanfes for Regulatory Affairs.- Maintian legal documents updated (CPP, GMPs, PoAs...)- Prepare regulatory responses to answer Health Authority queries.- Evaluate together with the Manager the impact of regulatory strategies and their actions in accordance with the legal framework and global policies.- Review and evaluate legal initiatives and changes in health legislation, measure their impact and report to global and local teams.
**WHO ARE WE LOOKING FOR****Experience & Education**- Bachelor's in Chemical-medical-biological areas.- Office packaging- 3 years of experience in Regulatory Affairs area.- Desirable management of biological, biotechnological and orphan drug products.- Advanced English.- Knowledge of national and international health regulations.- Management, preparation and control of legal,
technical and clinical documentation.- Management of pharmacopoeias- Requeriments analysis for the registration of pharmaceutical products in Mexico and/or Central America.- Experience in the New Molecules Committee and Subcommittee for the Evaluation of Biotechnological Products.
**Competences & Skills**- Analysis and decision-making processes.- Strategy planning.- Committed with foster diversity, equity and inclusive environment.
**LOCATION**:México City, México.
**_ Versión Español_****PROPOSITO DEL ROL**La posición será responsable de coordinar las actividades derivadas de las Gerencias de Asuntos Regulatorios para dar cumplimiento y seguimiento de la estrategia y plan regulatorio en concordancia con los objetivos de la compañía.La posición reporta a la Gerencia de Asuntos Regulatorios y está basada en Ciudad de México,
México.
**DESAFIOS EN LA POSICIÓN**- Trabajar activamente con la Gerencia de Asuntos Regulatorios para garantizar la planificación, seguimiento, alineación y cumplimiento de tiempos regulatorios
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.