Bayer posted a job you might be interested in December 13, 2014 at 05:01PM

Bayer



Senior Manager Global Regulatory Affairs CMC

San Francisco Bay Area, US - Pharmaceuticals

• Represents Regulatory Affairs in CMC development teams.

• 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, Bayer HealthCare 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 to Global Regulatory Teams 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 BLA-submissions 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 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 health authority approvals with product supply, to ensure regulatory CMC compliance.

• May act as mentor for newcomers within the Global RA CMC organization and seeks close alignment of CMC activities across the Therapeutic Area groups.

• Proposes and implements standards concerning CMC documentation in close co-operation with global, regional, and local RA functions, and Bayer Health Care Product Supply.

• Responsibility for achieving assigned global RA project objectives.

• Ensures adequate surveillance of the CMC related regulatory environment, particularly for assigned products (biotechnological, pharmaceutical, device combination) and anticipates and influences changes in this environment globally.







No salary provided



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