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

Umedica Labs; Navi Mumbai; On-site; INR 700,000 - 900,000; Full time

Job summary

Umedica Labs in Navi Mumbai is looking for a Regulatory Affairs professional to compile and prepare product dossiers for FDA submissions. Applicants should have a Bachelor’s or Master's degree and 5–7 years of experience in regulatory affairs, especially regarding FDA submissions.

The role requires strong organizational abilities, a keen eye for regulatory documentation standards, and proficiency in using regulatory tracking tools. Interested candidates can send their applications to [e-mail].

Qualifications

• 5–7 years of experience in regulatory affairs, preferably with FDA submissions.
• Strong knowledge of dossier compilation and regulatory documentation standards.
• Ability to coordinate inputs from multiple teams and produce structured, compliant documents.

Responsibilities

• Compile and prepare full product dossiers for FDA submission.
• Coordinate with internal teams to gather source documents.
• Prepare post-approval change filings and product maintenance reports.

Skills

Regulatory documentation standards

Organizational skills

Time-management skills

Coordination skills

Proficiency with regulatory tracking tools

Education

Bachelors or Master's degree

Tools

AI-assisted document review systems

Job description

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 [e-mail]