Join Sandoz in Kalwe as an Associate MRC, where you will manage marketing authorizations, prepare high-quality CMC documentation, and contribute to the lifecycle management of pharmaceutical products, ensuring regulatory compliance and supporting global health initiatives.
| Job Description | Details |
|---|---|
| Company Name | Sandoz |
| Post Name | Associate MRC |
| Employment Type | Full-time |
| Job Location | Kalwe, India |
| Job Requisition ID | 394699BR |
| Posted | 04/07/2024 |
| Apply By | Open until filled |
Major Accountabilities:
- Life Cycle Management: Manage Marketing Authorizations (MAs) and handle new submissions in major markets including EU, US, CAN, JP, AUS, BR, CN.
- Submissions Planning: Plan new submissions in Most of World (MoW) regions to meet targets.
- MA Transfers: Ensure timely and process-compliant Marketing Authorization transfers, maintaining product history.
- Documentation: Author and organize high-quality CMC documentation for health authority submissions, ensuring technical congruency and regulatory compliance.
- Variation Submissions: Manage work-sharing and super grouping variations submissions.
- Regulatory Responses: Prepare CMC responses to health authority questions during development, registration, and product lifecycle.
- Regulatory Evaluation: Assess change controls and quality events for regulatory impact, managing administrative changes.
Qualifications:
- Experience in lifecycle management of MAs, particularly in new submissions and lifecycle management in major markets.
- Ability to author and organize CMC documentation, ensuring compliance with regulatory strategies.
- Experience in regulatory evaluation of change controls and quality events.
Minimum Requirements:
- Division: SANDOZ
- Business Unit: Sandoz
- Location: India
- Site: Kalwe (Technical Operations) (Sandoz)
- Functional Area: Research & Development
- Job Type: Full time
- Employment Type: Regular
- Shift Work: No
About Sandoz:
Sandoz, a global market leader in Generics and Biosimilar medicine, is becoming a standalone organization. Joining Sandoz means contributing to the future of healthcare, innovation, and impacting millions of lives. Are you ready to make a difference?
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Important Notice and Disclaimer:- CareerBoostZone platform is a free Job Sharing platform for all the Job seekers. We don’t charge any cost and service fee for any job which is posted on our website, neither we have authorized anyone to do the same. Most of the jobs posted over Seekajob are taken from the career pages of the organizations. Jobseekers/Applicants are advised to check all the details when they apply for the job to avoid any inconvenience.
