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Alembic Pharmaceuticals logo
Deputy Manager / Manager - Regulatory Affairs - (Derma) Alembic Pharmaceuticals

12.0 - 15.0 years

16 - 20 Lacs

hyderabad

Work from Office

Role & responsibilities Health Canada ANDS (Abbreviated New Drug Submission): Comprehensive knowledge of Health Canada's ANDS pathway for generic drug approvals. Skilled in compiling complete ANDS dossiers (Modules 15) and interpreting regulatory guidance. Experienced in responding to Clarifax and NSNs with scientifically robust justifications. Proficient in eCTD submissions and managing post-approval changes (Level I/II). Drug Master File (API): Expertise in DMF referencing and coordination with API manufacturers for compliant submissions. EU & UK Generic Drug Registration In-depth understanding of EMA centralised, decentralised, and MRP procedures. Skilled in MHRA regulatory pathways post-...

Posted 2 weeks ago

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