Chapter Lead Regulatory

Detalles de la oferta

.Chapter Lead RegulatoryMajor TasksResponsible for all regulatory affairs activities of BPH and BCC including all maintenance and development product activities dealing with the relevant Health Authorities in relation to pharmaceuticals (Rx Non Rx), medical devices, cosmetics and food supplements marketing authorization/permission/notification.The position will have to consider and balance the business objectives and priorities of the divisional country heads.Where applicable, the position owner will supervise a dedicated Country CC RA Lead person in direct reporting line and manage the input of the regional CC Head through functional line in performance management.Decides on local regulatory strategic and operational matters to fulfill the local business strategies, in coordination with the local functions and with close coordination with Regional Head and other Global regulatory units. Ensures transparent, timely and efficient communication with business, supply chain and other local functions to achieve common decisions. Effectively manages priorities across divisions.Managerial responsibility of the regulatory affairs staff in the country, including talent management and people development.Responsible for the preparation of local budgets and the adequate hiring and training of Leads in the Mexico Regulatory Affairs organization; fully responsible for talent management, people development and the adequate hiring and training of staff.Responsible for the Mexico regulatory budget and resource allocations to meet regulatory needs.Decides on Mexico regulatory strategic and operational matters to support local business strategies, in coordination with Local functions, Regional and Global regulatory units. Ensures transparent, timely and efficient communication with business and other local functions to achieve common decisions.Proactively shape and influence the direction of regulatory policy and environment in Mexico; in alignment with Bayer's business and global policy priorities. Lead the development of regulatory policy strategies and network in the region in anticipation and implementation of new legislation, guidelines and regulatory processes. Represents Bayer at Industry Association groups.Responsible to represent Pharma as a competent reliable partner to the local Health Authorities in all regulatory matters. Oversees communication with Health Authority to ensure Bayer's one voice policy.Given the complex regional regulatory environment, determines the regulatory strategy for achieving earliest approval with appropriate labeling, in line with the business objectives.Responsible for Regulatory compliance of all PH products enabling business continuity. Ensure that marketed drugs are in conformance with local government guidelines and regulations


Salario Nominal: A convenir

Fuente: Jobtome_Ppc

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