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RA CMC Associate Manager I

RA CMC Associate Manager I

ConfidentialHyderabad / Secunderabad, Telangana, India
1 day ago
Job description

Summary

  • Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation and publication of REG CMC documentation for submissions to Health Authorities. In addition interact with HA's on REG CMC questions to support new product or post marketed launches.

About The Role

Major accountabilities :

  • Author high quality global CMC documentation for Health Authority submission throughout the product lifecycle, applying agreed CMC global regulatory strategies, current regulatory trends and guidelines.
  • Ensure technical congruency and regulatory compliance, meeting agreed upon timelines and e-publishing requirements.
  • Identify the required documentation and any content, quality and / or timeliness issues for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
  • As needed, coordinate / collect / store source documentation needed for direct submission to Health Authorities.
  • Actively participate as a member of the global RA CMC team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
  • Perform activities in support of the overall department such as data entry into the Regulatory Information Management System, other CMC database entry, or maintenance and operational activities as needed.
  • Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)
  • Minimum Requirements

  • Project Management.
  • Operations Management and Execution.
  • Collaborating across boundaries.
  • Why Novartis

    Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here : https : / / www.novartis.com / about / strategy / people-and-culture

    You'll receive : You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https : / / www.novartis.com / careers / benefits-rewards

    Commitment To Diversity And Inclusion

    Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

    Accessibility and accommodation

    Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [HIDDEN TEXT] and let us know the nature of your request and your contact information. Please include the job requisition number in your message

    Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here :

    https : / / talentnetwork.novartis.com / network

    Why Novartis : Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together https : / / www.novartis.com / about / strategy / people-and-culture

    Join our Novartis Network : Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up : https : / / talentnetwork.novartis.com / network

    Benefits and Rewards : Read our handbook to learn about all the ways we'll help you thrive personally and professionally : https : / / www.novartis.com / careers / benefits-rewards

    Skills Required

    Operations Management, Project Management, Data Entry, Regulatory Compliance

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    Associate Manager • Hyderabad / Secunderabad, Telangana, India

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