Senior Manager Regulatory Affairs

Key Responsibilities

1. Review registration dossiers in coordination with technical functions and in-/out-licensing partners to ensure compliance with current regulatory requirements across US, EU, ROW & Emerging markets.
2. Ensure the consistency, completeness, accuracy, and adequacy of regulatory submissions in line with applicable regulations and regulatory authority expectations.
3. Provide regulatory guidance for pre-approval and post-approval activities, including submissions, approvals, and management of regulatory commitments.
4. Coordinate with regulatory authorities and internal stakeholders on bioequivalence requirements, regulatory recommendations, and inactive ingredient levels during product development.
5. Ensure timely preparation and submission of responses to regulatory deficiencies, queries, and requests for additional information.
6. Lead and manage the Regulatory Affairs team, allocate responsibilities, monitor performance, and ensure timely execution of submissions and regulatory activities.
7. Coordinate with internal stakeholders, third-party manufacturers, and contract manufacturing partners to resolve regulatory issues and submission-related delays.
8. Manage product lifecycle activities, including renewals, variations, post-approval changes, change controls, and regulatory filings, to ensure continued product availability and compliance.
9. Review and approve the regulatory aspects of change controls and ensure timely filing and approval of variations across applicable markets.
10. Oversee regulatory activities related to NDC, drug listing, dossier compilation, filing and submissions, query responses, CARES Act requirements, and coordination of pharmacovigilance activities, as applicable.
11. Ensure continued product compliance with approved dossiers, applicable regulatory requirements, and regulatory commitments.
12. Review, provide regulatory inputs on, and ensure timely closure of QMS documentation, including Change Controls, Deviations, Incidents, and CAPAs in the EQMS.
13. Ensure timely and effective execution of regulatory-related activities in ERP, LIMS, eLog, AMS, and LMS systems.
14. Coordinate and deliver regulatory training programs through the Learning Management System (LMS).
15. Monitor and manage RSI (Reference Safety Information) updates in accordance with PRAC recommendations and other applicable regulatory authority requirements.
16. Monitor regulatory updates and assess their impact on existing products, approved dossiers, product lifecycle activities, and submission strategies.
17. Collaborate with Quality Assurance, R&D, Clinical, Pharmacovigilance, Manufacturing, Supply Chain, and other cross-functional teams to ensure regulatory compliance and business continuity.
18. Drive continuous improvement in regulatory processes, submission quality, compliance practices, and overall regulatory readiness.