Associate RA CMC Director
4 months ago
At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining ‘impossible’. There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.
Associate RA CMC Director
YOUR TASKS AND RESPONSIBILITIES
Work independently for marketed chemical and bio-products, CTA, NDA in China, including strategy discussion, dossier preparation, QC testing preparation, timely tracking and update the projects QC testing and CMC review status, foresee potential CMC queries of HAs. Mentor junior colleagues who will work with him/her to achieve pre-determine regulatory objectives. Provide insight and contribute to projects handled by other CMC colleagues. Serve as a primary contact person with HAs for CMC techincial review for assigned products/projects, keep CRT to be timely informed about the status. Take appropriate actions under different situations, manage and interact with Health Authority as liaison from regulatory CMC perspectives to ensure business growth. Interacts directly with CRT, GRT, Global Regulatory CMC/ global Product Supply to provide in-depth local know-how to form an aligned best possible regulatory strategy among global and local stakeholders. Participate, support and contribute the policy making via Bayer and industry platform and provide insight of the new regulations and policies. The person can provide insight to projects and system users for general topics at China RA department level. Contribute to tasks such as SOP/OI Taskforce, RA intelligence and competitor information etc. Ensure compliance of Company internal Policy/ system/ database/ responsible projects and local regulation compliant behavior for assigned projects.WHO YOU ARE
Advanced technical degree (Ph.D., D.V.M. or Pharm.D.) in life sciences with 6 years of regulatory experience or MS with 8 years of regulatory experience or BS with 10 years of regulatory experience Deep knowledge of local regulations, guidance is desirable Familarity of other agency’s regulation and guidance, e.g FDA, EMA, PMDA Deep knowledge of chemical drug or biological drug development, manufacture, analytical, quality control, GMP, drug therapy, statistical concepts is desirable Awareness of drug development and product maintenance requirements Good communication skills, verbal and written, are required Ability to work within a global team framework Strong analytical skills are required Demonstrated problem solving as applied to local regulatory issues-
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