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Position: Officer/Executives/Team Leader, Regulatory Affairs

Location: Mumbai Suburbs, Mumbai, Maharashtra

Job Description:

  • Compilation, review, and timely submission of error-free registration dossiers under CTD/ACTD/Country Specific for the International market (CIS, LATAM, AFRICA & ASEAN market).
  • Co-ordinate with various cross-functional team members as well with various functions within F&D, ADL, and manufacturing locations for collecting technical data required towards registrations / MOH/customer deficiencies.
  • Keeping up to date with changes in regulatory legislation and guidelines.
  • Ensuring compliance with regulations set by the regulatory agencies.

  • Ensuring that quality standards are met and submissions meet within stipulated timelines.
  • Review of Normative Documents (NDs) of products required for registration in CIS countries.
  • Knowledge about the CMC section required for dossier compilation.
  • Responsible for compilation & review of quality documents like MMF, RM/FP SPCN, STP, Stability Protocols & Report, Process Validation protocols & reports, Analytical method validations.
  • Liaise with marketing for the finalizing the product pipelines and providing required dossiers for submissions.
  • Liasioning with customers for contract manufacturing/loan licensing towards registrations of the products.
  • Responsible for the preparation of FDA documents for registration of the new product, license for new products (proforma), COPP data compilation & verification.

Qualification: Appropriately Qualified

Experience: 1-6 Years

Salary: 1,00,000 to 6,00,000 INR CTC/PA

Contact Details:

Ms. Rupa Maji

hr.ho@cironpharma.com

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