Drug Regulatory Affairs Manager - API

Preparation, review, and compilation of regulatory dossiers for API products.

Handling global regulatory submissions including DMFs and other registration dossiers.

documents in CTD/eCTD format.

Required Candidate profile

Strong knowledge of API regulatory requirements for global markets.

Experience in preparation and submission of DMF/ASMF/CEP and other regulatory dossiers.

Knowledge of ICH guidelines, GMP, CTD/eCTD

Perks and benefits

Thanks

Ravin Thakur