| Job Description | Job profile includes : • Guidance to R&D, ADL, Manufacturing, Quality for different regulatory requirements, Compilation of DMFs for US, Europe and other Regulatory agencies. • Review of all technical documents required for the submission of DMFs and ANDAs. • Preparation and submission of DMFs and ANDAs to regulatory authorities with the time frame. |
| Desired Profile | Candidate should be M.SC and well versed with ICH guideline, having thorough knowledge regulatory requirements of US, EU and other regulated markets. |
| Experience | 3 - 8 Years |
| Industry Type | Pharma/ Biotech/Clinical Research |
| Role | QA/QC Exec. |
| Functional Area | Production, Maintenance, Quality |
| Education | UG - B.Pharma - Pharmacy,B.Sc - Any Specialization PG - M.Pharma - Pharmacy,M.Sc - Any Specialization |
| Location | Vadodara/Baroda |
| Keywords | Regulatory Affairs RA, regulatory, Pharma, Alembic, |
| Contact | Mr Himanshu Jani Alembic Ltd. 3rd Floor, HRM Division, Corporate Building, Alembic-Gorwa Road VADODARA,Gujarat,India 390001 |
| Telephone | 91-265-3007702 |
| ra@alembic.co.in | |
| Website | http://www.alembic-india.com |
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