API Regulatory Professional

Qualification:

• MSc in Analytical / Organic Chemistry
• Pharmacy
• Life Science

Role Summary:

Seeking detail-oriented and motivated regulatory compliance specialists to manage and coordinate regulatory activities related to API filings across multiple regions. Responsibilities include preparing, reviewing, and submitting high-quality regulatory documents to ensure global compliance.

Key Responsibilities:

• Prepare, compile, and submit DMFs, ASMFs, and API regulatory dossiers to global authorities.
• Ensure timely updates, maintenance, and life cycle management of submissions.
• Monitor global regulatory changes and communicate to internal teams.
• Handle customer queries, letters of access, and technical data packages.
• Maintain database and tracking systems for submissions and commitments.
• Support regulatory and customer audits across all sites.

Key Skills & Competencies:

Passion to make a difference combined with:

• Strong analytical and strategic thinking.
• High attention to detail and ability to manage multiple projects/filings.
• Excellent written and verbal communication.
• Experience with Electronic Submission System (eCTD).
• Knowledge of pharmaceutical standards (USP, EU, JP).
• Understanding of documentation and filing requirements (US-FDA, EDQM, ANVISA, PMDA, etc.).
• Familiarity with ICH Q7, M7, Q11, Q12 guidelines.