COORDINADOR DE ASUNTOS REGULATORIOS (TEMPORAL)

Regulatory Sciences Coordinator Temporary role for 12months Location.
CDMX, Mexico JOB SUMMARY Coordinate activities related to dossier submission (paper and/or electronic) for Innovative drug products for country acceptability in terms of content, according to local regulations and requirements.
This includes HA query management.
Interact with key stakeholders, such as the LatAm Regional Hub to ensure the regulatory strategy has been executed in a timely manner.
Familiarize themselves with the latest changes in BoH legislation, and communicate this to the LatAm Regional Hub, to ensure the necessary systems and databases are updated as necessary.
Work in collaboration across the region to deliver efficiencies in regulatory submissions and processes.
Accountable for the Labeling and Non-Labeling submissions execution ensuring country acceptability in terms of content and alignment to local regulations and requirements.
This includes BoH query management.
Ensures the processes transparency and excellence in execution of regulatory strategies.
Work in collaboration across the organization with stakeholders (such as Product Strategist, Commercial, Operations) to deliver efficiencies in Regulatory submissions and processes.
Participation with Manager or Sr.
Manager to provide suggestions or comments in the documents worked by Trade Association.
JOB RESPONSIBILITIES Possess a through understanding of the market requirements, as well as the regulatory processes.
Coordinate the activities related to submissions of Innovative drug products.
Work closely with the LatAm Regional Hub to ensure submissions are ready to file, and provide the necessary information to ensure internal systems and databases are updated.
Coordinate the routine monitoring of Agency’s website for information related to product registration, line extensions and post-approval changes.
Understand local regulations and trends.
Ensure the team keeps current with the BoH legislation, as well as updates the regulatory information on Pfizer’s intranet.
Coordinate the review of submission ready dossiers, ensuring that submissions fully meet the local regulatory requirements.
This includes BoH query response.
Coordinate the preparation of the registration license renewal for all registered products.
Support tender processes by providing updated regulatory documents.
Complete departmental training in a timely manner to address corporate and regulatory needs.
As applicable, contribute to local regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention.
Develop detailed understanding of regulatory guidelines and technical requirements in the LatAm countries.
Qualifications.
Education.
Pharmacist degree Experience.
About 4 years as a Senior Regulatory Sciences Analyst.
Relevant pharmaceutical experience Technical Skill Requiremtents.
Knowledge of local BoH requirements, as well as the requirements for the markets in the Cluster.
Technical and scientific knowledge of pharmaceutical products.
Proficiency in the English language is preferred.
Customer-oriented Results-oriented Negotiation Planning Organized Decision making Communication Team player Change agile Declaración de igualdad de oportunidades Nos comprometemos a garantizar que todas las personas interesadas en trabajar en Pfizer sean tratadas por igual, sin discriminación por motivos de género, reasignación de género, orientación sexual, estado civil, raza, color, nacionalidad, origen étnico o nacional, religión o creencia, discapacidad o edad.
Regulatory Affairs #LI-PFE Una carrera en Pfizer es como ninguna otra.
En nuestra cultura de propiedad individual, creemos en nuestra capacidad para mejorar el futuro de la sanidad y en nuestro potencial para cambiar millones de vidas.
Estamos buscando talento nuevo para unirse a nuestra comunidad global, para descubrir nuevas terapias innovadoras que hagan del mundo un lugar con mejor salud.