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About Company

The Executive MRC position at SANDOZ in Kalwe, India, involves extensive responsibilities in regulatory affairs and CMC (Chemistry, Manufacturing, and Controls) documentation. Here’s a breakdown of the key responsibilities and requirements:

Position Name :

Executive MRC In Regulatory Affairs

Organization :

Sandoz

Qualification:

B.Pharm, M.Pharm, Msc, BSc

Experience:

1 to 8 Years

Salary:

Not disclosed

Location:

india

Major Accountabilities

  1. Life Cycle Management of Marketing Authorizations (MAs):
    • Manage MAs throughout their life cycle, focusing on major markets like EU, US, Canada, Japan, Australia, Brazil, China.
  2. New Submissions and Planning:
    • Plan and execute new submissions in Most of World (MoW) regions as per set targets.
  3. MA Transfers:
    • Responsible for transferring MAs and maintaining product history within defined timelines and processes.
  4. CMC Documentation:
    • Author and organize high-quality CMC documentation (dossiers) for health authority submissions, ensuring technical congruency, regulatory compliance, and meeting e-publishing requirements.
  5. Variations Submissions:
    • Handle work-sharing and super grouping variations submissions.
  6. CMC Responses:
    • Prepare CMC responses to health authority questions during development, registration, and throughout the product lifecycle.
  7. Regulatory Evaluation:
    • Evaluate change controls and other quality events for regulatory impact, including administrative changes.

Minimum Requirements

  • Experience in regulatory affairs, specifically in CMC documentation and submissions.
  • Familiarity with international regulations, especially in major markets.
  • Strong organizational skills and ability to manage multiple projects.
  • Excellent communication skills and ability to work effectively in a team.

Application Link