Executive - Regulatory Affairs

Job Description:

Responsibilities

• Strong knowledge of USFDA, ICH guidelines, regional regulations (US, EU, India), and submission formats.
• Prepare, compile, and submit regulatory dossiers (e.g., CTD/eCTD) for new drug applications (NDAs), ANDAs, MAAs, and post-approval changes
• Support regulatory strategy development for new products and markets
• Coordinate with cross-functional teams (CDMO, R&D, Manufacturing) to gather required documentation and data.
• Respond to queries and deficiency letters from regulatory authorities
• Maintain regulatory databases and track submission timelines and approvals

Qualification & Experience

• Graduate : M.Pharm
• Experience
• Tenure : 2- 5 years of relevant experience