Global Regulatory Affairs Lcm&e - Tlahuac, México - Bayer

Bayer

Empresa verificada

Tlahuac, México

hace 3 semanas

Publicado por:

Rodrigo Fernández

Reclutador de talento para beBee

Descripción

Global Regulatory Affairs LCM&E

Your Tasks and Responsibilities

Responsibility for the regulatory strategy with regard to Chemistry Manufacturing and Controls (CMC) for assigned products in close cooperation with the relevant global, regional, and country RA functions, BHC Product Supply, Medical, Drug Safety and Marketing, to ensure early identification of major regulatory hurdles and issues with regard to CMC related topics, regulatory guidelines and legal requirements, and coordination of respective corrective actions. Provides active input into GRTs for assigned projects to ensure timely submission and first cycle approval.
Responsibility for timely availability and final content of CMC IND/IMPD, NDA/MAA, sNDA, or BLAsubmissions for assigned products to Health Authorities, including responses to health authority questions.
Responsibility for the CMC change management for assigned development and marketed products, which includes providing regulatory assessments, tracking of CMC changes and processing of requests for related documentation(evaluation, consolidation, prioritization and review), responsibility for coordination of responses to health authority questions, and for implementation of CMC changes after HA approvals with product supply, to ensure regulatory CMC compliance.
Ensures adequate surveillance of the CMCrelated regulatory environment for assigned products and anticipates and influences changes in this environment globally.
Manages scientific support of assigned marketed products with respect to regulatory aspects and Labeling in close cooperation with the respective TA heads.
Coordinates and ensures the timely generation of regulatory documents adhering to global, regional and local requirements.
Responsibility for the support of assigned marketed products to ensure the successful maintenance of and lifecycle (variations, renewals or deficiency letter), ensuring regulatory guidelines are met.
Manages the preparation of registration dossiers related to assigned products and proactively identifies and tracks regulatory activities and /or issues and risks and brings these to the attention of RA CC infrastructure management as necessary.
Coordinates the publishing and dispatching activities of the variations to the respective local regulatory affairs as well as submitting through EU gateway.

Who You Are