Manager - Regulatory Affairs

Assistant Manager - Regulatory Affairs

Location: Nahur

Experience: 5 to 8 Years in regulatory affairs

Markets: ROW Market

Financial Perspective:

- Ensure timely submission and approval of regulatory dossiers to contribute to revenue generation.

- Optimize regulatory submission timelines to avoid market entry delays.

- Minimize costs related to dossier submission by ensuring first-time-right documentation.

Customer Perspective:

- Ensure compliance with Regulatory Authority guidelines for dossier submissions.

- Effectively communicate with regulatory authorities to address queries and obtain timely approvals.

- Maintain strong coordination with internal teams (R&D, QA/QC, Purchase, Mfg sites, vendors) to ensure timely dossier compilation.

- Provide regulatory support for product registrations across various markets.

Internal Process Perspective:

- Prepare, compile, and submit high-quality regulatory dossiers (CTD, eCTD, and other formats).

- Achieve annual targeted submission and registration goals.

- Monitor and follow up on registration statuses and respond to deficiency queries within deadlines.

- Maintain regulatory databases and ensure compliance with regulatory quality standards.

- Review and approve Change Control Documents related to regulatory submissions.

Learning & Growth Perspective

- Stay updated on changing regulatory guidelines and global submission requirements.