10 - 20 Years
-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|
Reputed Client of Prominent Consultant
|About Company||Reputed API / Pharmaceutical Company of India|
|Contact Person||Mr. Pranit Pamar|