10 - 20 Years
Vadodara
Job Description
-Heading API Regulatory section, Planning and execution of RA activities.
-Evaluation of changes in pharmacopoeias with respect to APIs manufactured and making necessary changes/inclusion in related documents.
-Interaction with cross functional team members of Marketing, QC, QA, Production and R&D on various commercial/technical issues required for compilation documents and responding to queries etc.
-Key role in making marketing/regulatory strategies with respect to APIs and their starting materials and intermediates.
-Establish specifications for new drug substances / key starting material and review of specifications, test procedures, batch manufacturing records and validation reports, etc.
-Involvement in various day to day RA activities to implement up to date knowledge with regard to guidelines and regulations.
-Handling of Customers and Authorities queries Document review ISO documentation
-Regulatory Support to Plant / various departments
-Change control review
| Salary | 8 Lac To 20 Lac P.A. |
| Industry | Manufacturing / Production / Quality |
| Work Experience | 10 - 20 Years |
| Qualification | B.Pharma, B.Sc, M.Pharma, M.Sc |
Key Skills
Company Profile
| Company Name | Reputed Client of Prominent Consultant |
| About Company | Reputed API / Pharmaceutical Company of India |
| Contact Person | Mr. Pranit Pamar |
| Address | Vadodara |
| Mobile | 9979366347 |
| Email ID | pranit@prominentconsultant.com |