Regulatory Affairs Cmc Manager Plasma-derived Therapies Business Unit

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Regulatory Affairs CMC Manager, Plasma-Derived Therapies Business Unit
Duties: Proactively contributes to the development and implementation of innovative CMC regulatory strategies in close collaboration with relevant R&D, PDT BU R&D and Commercial functions to obtain, maintain and extend PDT BU product registrations in the United States, Japan, the European Union, Canada and emerging markets. Maintains optimal GRA CMC Regulatory Affairs effectiveness for ongoing development and lifecycle management activities for assigned programs. Provides proactive guidance and regulatory strategies to support PDT product teams. Remains knowledgeable about current CMC regulations and guidances and interprets the global CMC regulatory environment to provide proactive guidance to internal stakeholders based on technical and regulatory knowledge and to guide the development of strategic and tactical regulatory plans. Proactively identifies and assesses regulatory and compliance risks associated with product development and life-cycle management activities. Creates high quality, compliant CMC regulatory documents (eg, Core Dossiers, CTAs, MAAs, NDS, Variations and other relevant regulatory CMC filings) within defined timelines as per PDT BU objectives. Interfaces with key GMS and PDT BU R&D functions in the preparation, review and approval of CMC regulatory filings to support early and late stage development assets, and the maintenance or expansion of approved Plasma-Derived Therapies globally. Proactively develops and fosters appropriate relationships with global regulatory agencies, especially the US Food and Drug Administration and international regulatory agencies to develop effective, professional relationships and advance a positive company image. In partnership with other relevant functions, assists in the conduct of regulatory agency inspections and compliance audits. Ensures compliance in all GRA PDT BU activities. Acts as an ambassador for the PDT BU Regulatory Affairs organization to influence and shape the external regulatory and policy environment. Ensures a culture of transparency, innovation and teamwork. Is approachable to colleagues across and is open to the ideas of others.

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