Sr. Executive Regulatory Affairs/ Executive (Finished Formulation)
Mahesh Bhupatrai Mehta · Mumbai · onsite · Posted 57d ago
₹3.2L - ₹4.0L PA3–4 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
- Complete understanding of requirement and regulation of ROW/ LATAM/African countries/MENA/ASEAN markets wrt new submission, registration and variation.
- Review and/ compilation of country specific/Preparation of dossier in CTD / ACTD for new submission/ variation submission.
- Prior experience of carrying out hight quality CMC Review documents of technical documents require for registration i.e., BMR, Process validation, Method validation, registration documents etc.
- Coordinate for Artwork preparing.
- Draft confirmation of licenses - COPP, FSC, PP etc
- Knowledge and understanding of ICH guidelines.
- Coordinating for samples and documents & working standard.
- Coordination with Advocate for Trade mark registration & record.
- Tender documents compilation.
- DGFT, Pharmexcil, FSSAI, RCMC application.
- Plant visits intermittently if necessary.
- GSTIN generation & recording of details.
Sourced from naukri
Skills
coordination and communication skills. Proficiency in dossier preparationCTD/ATCD/ CMC/technical review/MOH queries. Strong understanding of regulatory requirements for semi-regulated and non-regulated markets. Excellent documentationDossierCTDDMF