Bayer
Country Head of Regulatory Affairs
Moscow, Russian Federation, RU - Pharmaceuticals, Medical Practice, Medical Devices
Major tasks and responsibilities of position
- 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.
- Managerial responsibility of the regulatory affairs staff in the country, incl talent management and people development. Responsible for
the preparation of local budgets and the adequate hiring and training of staff. - Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems,
creation and maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted. Manages training and audits of the quality system. - Ensure regulatory compliance for a sustainable life-cycle management: Labeling and CMC changes are performed in accordance with
local regulations and relevant Bayer SOPs. - Responsible to represent BHC as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely
approvals with optimal labels. Proactively shapes the regulatory environment in the country. Builds strong regulatory networking
with national regulators, local industry organizations and key opinion leaders. Oversees communication with Health Authority to ensure Bayer one voice policy. - Building relationships with the Health Authorities, as key customers, is essential in achieving business goals. The relationship is
based on trust, transparency and partnership and is clearly a major focus of this function.
No salary provided
Posted April 12, 2015 at 03:02PM from LinkedIn https://www.linkedin.com/jobs?viewJob=&jobId=44230754&trk=api*a130653*s139051*
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