Role & responsibilities

- Lead the planning,execution, and performance of the US regulatory program.
- Report progress, risks, and outcomes directly to the AGM.
- Supervise and develop the US Regulatory Executive.
- Review and approve all submission documents before filing with the FDA.
- Ensure dossiers meet FDA format standards and compliance requirements.
- Manage comment resolution cycles with FDA, internal reviewers, and clients, ensuring all issues are documented and closed.
- Act as the primary regulatory contact for US clients and distribution partners.
- Provide regulatory opinions,review partner documents, and support their compliance needs.
- Conduct due diligence for in-licensing, out-licensing, and business development activities.
- Assess regulatory risks and produce structured due diligence reports.
- Lead implementation of regulatory management systems and submission workflow automation.




- Configure, test, and train the team on new systems.
- Establish quality KPIs,track performance, and report submission quality metrics to the AGM.
- Drive initiatives to reduce agency queries and improve submission quality.

Preferred candidate profile

- Bachelors or Masters degree in Pharmacy.
- Robust knowledge of FDA regulatory requirements and submission standards.
- Proven experience in dossier review, comment resolution, and regulatory risk assessment.
- Excellent leadership,communication, and client management skills.
- Experience with regulatory systems automation and performance tracking.

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

📌 Manager - Regulatory Affairs - US Market (Navi Mumbai)
🏢 Umedica Labs
📍 Navi Mumbai