- Co-ordination with QA, QC, R&D;, manufacturing, and other stakeholders to collect submission documents.
- Ensure the adequacy, completeness, and compliance of all documents received from cross-functional teams
- Review regulatory dossiers in CTD/eCTD/ACTD/Country specific checklist in accordance with global health authority requirements.
- Review responses to regulatory queries from global health authorities and business partners for accuracy and compliance.
- Ensure timely updates in Regulatory Information Management Systems (RIMS), including submission records, deficiency tracking, document archiving, and dossier trackers.
- Define strategies for responding effectively to regulatory deficiencies and queries. Review responses prepared for regulatory authority queries to ensure scientific accuracy and regulatory compliance.
- Review approval packages.
- Review and approve change controls and assess their regulatory impact across global markets.
- Review documentation related to renewals, variations,



and post-approval changes as part of product lifecycle management activities.
- Ensure timely submission of samples required for registration purposes across different markets.
- Review necessary documents for GMP applications, including site-related submissions where applicable.
- Ensure timely processing of agency invoices and regulatory-related payments.
- Review national submission and translation activities by coordinating with local consultants and translators following DCP approval.
- Generate GDUFA cover sheets for ANDA fees, Facility Fees, and Program Fees, and coordinate agency, partner, and consultant payments.
- Support the preparation and review of Scientific Advice Meeting and Pre-ANDA meeting packages.
- Perform additional duties and responsibilities assigned by department leadership to support regulatory operations and business objectives.

📌 Regulatory Affairs Manager (Bengaluru)
🏢 Biocon
📍 Bengaluru