(3 Days Left) Expert Regulatory Cmc

4 weeks 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

  • ▷ Immediate Start! Cmc Regulatory Affairs Associate Director Ii

    3 weeks ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title CMC Regulatory Affairs Associate Director IIGlobal Career Level EIntroduction to roleAre you a strategically focused Regulatory CMC professional eager to play an integral part in bringing life-changing medicines to patients If so please read on As a CMC Regulatory Affairs Associate Director II you will provide essential CMC Regulatory Strategy ...

  • International Cmc Regulatory Affairs Associate

    2 weeks ago

    Bengaluru, Karnataka, India AstraZeneca Full time

    **Job Title - Associate - International CMC Regulatory Affairs** **Career Level - C** Lead the way for a new breed of solutions-oriented Regulators Champion a new approach to Regulatory that supports quick decision-making and balanced risk-taking. Curious enterprise-thinkers we proactively take a strategic approach earlier in the product lifecycle to get...

  • Cmc-ra Associate Ii

    2 weeks ago

    Bangalore, Karnataka, India AstraZeneca Full time

    Job Title CMC RA Associate II Introduction to role Are you ready to make a significant impact in the world of Chemistry Manufacturing and Control CMC documentation As a CMC RA Associate II you ll be at the forefront of supporting submissions for both original marketing applications and the maintenance of existing licenses for marketed products Join...

  • Regulatory Affairs

    2 weeks ago

    Bangalore, India vueverse. Full time

    Position Overview: We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions. Key responsibilities: Prepare Variation documents and/or evaluate post-approval CMC changes in...

  • Regulatory Affairs

    2 weeks ago

    bangalore, India vueverse. Full time

    Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...

  • Regulatory affairs specialist

    3 weeks ago

    Bangalore, India Biocon Biologics Full time

    Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...

  • Regulatory Affairs Specialist

    24 hours ago

    bangalore, India Biocon Biologics Full time

    Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...

  • Manager global regulatory affairs

    1 week ago

    Bangalore, India Biocon Biologics Full time

    Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio •...

  • Regulatory Affairs

    1 week ago

    Bengaluru, Karnataka, India, Karnataka vueverse. Full time

    Position Overview:We are seeking a detail-oriented RA-CMC Associate to support end-to-end submissions for global markets. Required exposure includes Lifecycle Management (LCM), Veeva Vault RIM, and complex Initial and Variation submissions.Key responsibilities:Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global...

  • Regulatory Professional

    7 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:RA CMC & Device**About the Department** - RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the...