RA EXECUTIVE / SR. EXECUTIVE

Job description

1.0 Compile and prepare full product DMF for FDA submission, ensuring compliance with format requirements. 2.0 Coordinate with internal teams to gather source documents and cross-check for completeness 3.0 Review the documents against the FDA guidance’s assuring regulatory compliance 4.0 Serve as a primary point of contact for customer / Regulatory queries and systematically address technical deficiencies. 5.0 Keep knowledge up to date with regard to regulatory guidelines 6.0 Track submission timelines and maintain regulatory documentation records. 7.0 Prepare, review, and submit high-quality regulatory documents for customer approval. 8.0 Monitor national and international guidelines (like FDA, EMA, CDSCO, or ICH) to guarantee complete compliance across product documents. 9.0 Ensure compliance with cGMP, EHS, Data Integrity, and regulatory requirements. 10.0 To have basic knowledge related to working on software and working on Agency portals (Regulatory markets and / Sugam - India).