Officer/Senior Officer - Regulatory Affairs (API Experience)

Alivus Life Sciences; Solapur; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Alivus Life Sciences in India is seeking a Regulatory Submissions & Maintenance specialist to compile, review, and submit API DMFs (USDMF, ASMF) in eCTD/NeeS for global markets including US FDA, EMA, ANVISA, Health Canada, TGA, Medsafe and ROW agencies.

You will prepare CEP applications, manage DMF amendments and annual updates, and maintain CTD Module consistency with ICH and agency guidelines, while coordinating with R&D, QA, QC, Manufacturing and Supply Chain for compliant documentation.

Qualifications

• Experience with API DMFs (USDMF, ASMF) and eCTD/NeeS submission formats.
• Strong understanding of CTD modules and regulatory data integrity.
• Ability to align CTD sections with ICH and agency guidelines.

Responsibilities

• Compile, review, and submit API DMFs (USDMF, ASMF) in eCTD/NeeS format for global markets.
• Prepare and manage CEP applications (new submissions, revisions, renewals, group submissions).
• Handle DMF amendments/updates, annual updates, and notifications per agency requirements.
• Maintain CTD Module sections in line with ICH, FDA, EMA, ANVISA and other guidelines.
• Maintain regulatory databases, submission trackers, and archival systems for APIs.
• Support change management filings related to process optimization, vendor/site changes, specs, and analytical methods.
• Work with R&D, QA, QC, Manufacturing, and Supply Chain to obtain compliant technical docs.
• Support regulatory inspections and audits by providing documentation and responses.

Skills

Regulatory Submissions

DMF/CTD Knowledge

ICH Guidelines

Documentation Management

Cross-functional Collaboration

Job description

Regulatory Submissions & Maintenance

• Compile, review, and submit API DMFs (USDMF, ASMF) in eCTD / NeeS format for regulatory filings for global markets including US FDA, EMA, ANVISA, Health Canada, TGA, Medsafe and ROW agencies.
• Prepare and manage CEP applications (new submissions, revisions, renewals, and group submissions).
• Handle DMF amendments/updates, annual updates, and notifications as per various agency requirements.

Agency & Customer Communication

• Ensure accuracy, consistency, and compliance of CTD Module sections with current ICH, FDA, EMA, ANVISA and other applicable guidelines.
• Maintain regulatory databases, submission trackers, and archival systems for APIs.
• Support change management filings related to process optimization, vendor change, site changes, specifications, and analytical methods.

CrossFunctional Coordination

• Work closely with R&D, QA, QC, Manufacturing, and Supply Chain teams to obtain compliant technical documentation.
• Support regulatory inspections and audits by providing documentation and responses related to API registrations.