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Position: Officer/Executives/Team Leader, Regulatory Affairs
Location: Mumbai Suburbs, Mumbai, Maharashtra
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
Ms. Rupa Maji