Role & responsibilities

- Compile and prepare full product dossiers for FDA submission, ensuring compliance with format requirements.
- Coordinate with internal teams to gather source documents and cross-check for completeness.
- Prepare post-approval change filings and product maintenance reports under Manager direction.
- Prepare client and partner document packs, including dossier summaries, product certificates, regulatory status reports, and due diligence documents.
- Ensure accuracy and timely delivery of high-frequency client requests.
- Manage submission tracking systems, deadline calendars, and annual maintenance schedules for all approved US products.
- Monitor timelines to ensure no submission deadlines are missed.

Preferred candidate profile





- Bachelors or Master's degree.
- 5–7 years of experience in regulatory affairs, preferably with FDA submissions.
- Solid knowledge of dossier compilation and regulatory documentation standards.
- Excellent organizational and time-management skills.
- Ability to coordinate inputs from multiple teams and produce structured, compliant documents.
- Proficiency with regulatory tracking tools and AI-assisted document review systems.

Interested candidates can apply or share their resume on [email protected]

📌 Executive / Sr. Executive - Regulatory Affairs - US Market. (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai