Research AssociateJobs Opening in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBResearch Associate
Cadila Pharmaceuticals Ltd
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Applied
Posted: 17 Dec 25
Job Description
- Preparation, review and submission of Drug Master Files for various regulated and less regulated markets.
- Preparation, review and submission of DMF, Annual updates and submission to US, Canada, China, Korea authorities through online submission portal in eCTD/CTD format.
- Preparation and review of DMF and query responses to EDQM via CESP in eCTD format.
- Preparation of closed part DMF for various non-regulated markets.
- Preparation of customer responses for various regulated & less regulated markets.
- Evaluation of process and Route of synthesis.
- Collection and compilation of documents to prepare Regulatory submission and customers.
- Review STP’s, Change controls of unit I & unit -II, AMV, Impurity profile and characterization of Drug substances.
- Review of Applicant’s Part for various regulated and less regulated markets.
- Preparation of LOA’s, CEP LOA’s and declarations for various customers and authorities.
- Preparation and review of regulatory guidelines for internal reference purpose.
- Verification of current monograph during DMF filing.
Job Particulars
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2809597
Job Category Regulatory Affairs
Locality Address
State
Country India
About Company
Cadila Pharmaceuticals Ltd
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