Regulatory Affairs Manager

Biocon; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Biocon in Bengaluru is seeking a Regulatory Operations professional to coordinate with QA, QC, R&D, manufacturing and other stakeholders to assemble submission documents and ensure completeness and compliance.

The role involves reviewing regulatory dossiers, responding to agency queries, maintaining RIMS records, and supporting lifecycle activities including renewals, variations, and post-approval changes to ensure smooth approvals across global markets.

Responsibilities

• Coordinate with QA, QC, R&D, manufacturing and other stakeholders to collect submission documents.
• Ensure adequacy, completeness, and compliance of documents from cross-functional teams.
• Review regulatory dossiers in CTD/eCTD/ACTD checklists per global health authority requirements.
• Review responses to regulatory queries from health authorities and business partners for accuracy and compliance.
• Ensure timely updates in Regulatory Information Management Systems (RIMS) including submission records and dossier trackers.
• Define strategies for responding to regulatory deficiencies and queries and review responses for accuracy.
• Review approval packages for regulatory readiness and accuracy.
• Review and approve change controls and assess regulatory impact across global markets.
• Review documentation related to renewals, variations, and post-approval changes in product lifecycle management.
• Ensure timely submission of samples required for registration across markets.
• Review documents for GMP applications, including site-related submissions where applicable.
• Ensure timely processing of agency invoices and regulatory payments.
• Coordinate national submission and translation activities with local consultants and translators after DCP approval.
• Generate GDUFA cover sheets for ANDA fees and coordinate agency, partner and consultant payments.
• Support preparation and review of Scientific Advice Meeting and Pre-ANDA meeting packages.
• Perform additional duties assigned by leadership to support regulatory operations and business objectives.

Job description

Job Description

1. Co-ordination with QA, QC, R&D, manufacturing, and other stakeholders to collect submission documents.

2. Ensure the adequacy, completeness, and compliance of all documents received from cross-functional teams

3. Review regulatory dossiers in CTD/eCTD/ACTD/Country specific checklist in accordance with global health authority requirements.

4. Review responses to regulatory queries from global health authorities and business partners for accuracy and compliance.

5. Ensure timely updates in Regulatory Information Management Systems (RIMS), including submission records, deficiency tracking, document archiving, and dossier trackers.

6. Define strategies for responding effectively to regulatory deficiencies and queries. Review responses prepared for regulatory authority queries to ensure scientific accuracy and regulatory compliance.

7. Review approval packages.

8. Review and approve change controls and assess their regulatory impact across global markets.

9. Review documentation related to renewals, variations, and post-approval changes as part of product lifecycle management activities.

10. Ensure timely submission of samples required for registration purposes across different markets.

11. Review necessary documents for GMP applications, including site-related submissions where applicable.

12. Ensure timely processing of agency invoices and regulatory-related payments.

13. Review national submission and translation activities by coordinating with local consultants and translators following DCP approval.

14. Generate GDUFA cover sheets for ANDA fees, Facility Fees, and Program Fees, and coordinate agency, partner, and consultant payments.

15. Support the preparation and review of Scientific Advice Meeting and Pre-ANDA meeting packages.

16. Perform additional duties and responsibilities assigned by department leadership to support regulatory operations and business objectives.