Officer/Executive Regulatory Affairs -API

Emcure; Pune District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Emcure in Pune, India seeks a regulatory affairs professional to prepare and file DMFs, ASMFs, CEPs, and related submissions for US, Europe, and Canada. You will manage submissions via DocuBridge and EDUCE and maintain regulatory documents to ensure compliance with global requirements.

Qualifications include B.Pharm/M.Pharm/M.Sc, with experience in DMF/ASMF/CEP submissions and regulatory documentation management for multiple markets.

Qualifications

• Preparation and filing of original DMFs and amendments.
• Submission of ASMFs and CEP applications for EU and Canada.
• Maintaining regulatory documentation to ensure US/EU/Canada compliance.

Responsibilities

• Prepare and file DMFs, ASMFs, CEPs and related documents.
• Submit regulatory filings through DocuBridge and EDUCE properly.
• Maintain up-to-date regulatory records and ensure global compliance.

Skills

DMF submissions

ASMF submissions

CEP submissions

DocuBridge

EDUCE

Education

B.Pharm

M.Pharm

M.Sc.

Tools

DocuBridge

EDUCE

Job description

• Preparation and filing of original DMFs, amendments, and annual reports for USFDA.
• Preparation and submission of ASMFs, ASMF updates, CEP applications/revisions for Europe and regulatory documents for Canada market.
• Handling regulatory submissions through DocuBridge & EDUCE software.
• Maintaining regulatory documentation and ensuring compliance with US, European, and Canadian regulatory requirements.

Preferred Skills: Experience in DMF, ASMF, CEP submissions, DocuBridge & EDUCE software, and good knowledge of US, EU, and Canada regulatory requirements.

Qualification : B.Pharm / M.Pharm / M.Sc.