Executive / Sr. Executive - Regulatory Affairs - US Market.

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.
• Strong 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 vaishnavi.k@umedicalabs.com