Job Description | Details |
---|---|
Company Name | Novartis Healthcare Private Limited |
Post Name | RA CMC Associate Manager-II |
Employment Type | Regular |
Job Location | Hyderabad (Office), India |
Expected CTC | 6.6 LPA |
Vacancy | Not specified |
Starting Date of Online Application | May 30, 2024 |
Last Date of Online Application | Not specified |
Summary For Novartis Healthcare Recruitment Drive:
The RA CMC Associate Manager-II is responsible for regulatory activities related to chemistry, manufacturing, and control (CMC). This role involves preparing and publishing regulatory CMC documentation for Health Authority submissions, ensuring compliance with regulatory guidelines and timelines.
Major Accountabilities For Novartis Healthcare Recruitment Drive:
- Author high-quality global CMC documentation for Health Authority submissions, adhering to global regulatory strategies and guidelines.
- Ensure technical accuracy and regulatory compliance, meeting project timelines and e-publishing requirements.
- Coordinate and manage source documentation required for direct submission to Health Authorities.
- Contribute to global regulatory strategy discussions and identify critical issues.
Key Performance Indicators For Novartis Healthcare Recruitment Drive:
- Produces high-quality regulatory documentation without delays.
- Delivers reliable, timely, and accurate information to stakeholders.
- Ensures regulatory documentation meets Novartis and global regulatory guidelines.
- Builds collaborative partnerships with stakeholders.
Minimum Requirements For Novartis Healthcare Recruitment Drive:
Work Experience:
- Experience in cross-cultural environments, project management, and operations management.
- Ability to collaborate effectively across boundaries.
Skills:
- Proficiency in documentation management, life sciences, operational excellence, and regulatory compliance.
Languages:
- Fluent in English.
Why Novartis:
Novartis is dedicated to improving and extending people’s lives through innovative science and a supportive community. The company values collaboration, support, and inspiration among its employees.
For more information on benefits, rewards, and Novartis’ commitment to diversity, visit their career page.
For those interested in staying connected with Novartis career opportunities, join the Novartis Network.
This role is within the Development division at Novartis Healthcare Private Limited in Hyderabad, India, under the Research & Development functional area.
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