Prominent Consultant


Job openings for manager head regulatory affairs api in vadodara

Manager / Head - Regulatory Affairs (API)

Vadodara


-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

Experience 10 - 20 Years
Salary 8 Lac To 20 Lac P.A.
Industry Manufacturing / Production / Quality
Qualification B.Pharma, B.Sc, M.Pharma, M.Sc
Key Skills Regulatory Affairs Quality Assurance Pharmaceutical Execution

About Company

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