(3 Days Left) Expert Regulatory Cmc

1 day ago

Bangalore Karnataka, India Merck Group Full time

Work Your Magic with us Ready to explore break barriers and discover more We know you ve got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people s lives with our solutions in Healthcare Life Science and Electronics Together we dream big and are passionate about caring for our rich mix of people customers patients and planet That s why we are always looking for curious minds that see themselves imagining the unimageable with us Your Role Support and implement CMC Regulatory Intelligence activities NB this is a non-product specific role Databases e g CMC Regulatory Country Requirements Life Cycle Management Investigational Medicinal Product Catalogues Wiki-handbook maintenance and their continuous improvement including liaison with external data providers as appropriate Active participation in Change Control Process meetings Chair of Quality Regulatory Assessment Committee QRAC meetings and monthly updates sessions author co-author of Position Papers and responses to Reg CMC queries SME for guidelines revision etc Ensure alignment between CMC Regulatory Intelligence and GRA CMC Device teams e g by improving interoperability agility engagement and cohesion Deliver from a non-product specific perspective on small molecules large molecules medical devices i e drug-device combinations with regards to marketed post-approval activities as per CMC Regulatory Intelligence Road maps Participation in Trade Association calls in listening learning observer mode by leveraging the discussion and lessons learnt onto CMC Regulatory Intelligence databases Provide support on digitalization projects Effective utilization of Veeva system for all the CMC regulatory activities Who You are Education Degree in a Life Science Medical PharmD or related discipline minimum MSc or equivalent degree Higher degree preferable e g PhD in a scientific discipline or education in Regulatory Affairs 10 years of overall work experience e g generated in Pharma environment Competent authority Academia R D Consultancy related and applicable to this CMC Regulatory Intelligence role Minimum 5 years of Global CMC regulatory experience What we offer We are curious minds that come from a broad range of backgrounds perspectives and life experiences We celebrate all dimensions of diversity and believe that it drives excellence and innovation strengthening our ability to lead in science and technology We are committed to creating access and opportunities for all to develop and grow at your own pace Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress Apply now and become a part of our diverse team

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