Senior Manager Regulatory Affairs (ROW Markets)

Key Responsibilities

1. Review registration dossiers in coordination with technical functions and in/out-licensing partners to ensure compliance with current regulatory requirements of ROW markets.
2. Ensure consistency, completeness, and adequacy of regulatory submissions in line with applicable regulations and agency expectations.
3. Provide strategic regulatory guidance for pre-approval and post-approval activities, including submissions, approvals, and regulatory commitments.
4. Coordinate with regulatory authorities on bioequivalence requirements, recommendations, and inactive ingredient levels during product development.
5. Ensure timely preparation and submission of responses to regulatory deficiencies and queries.
6. Lead and manage the Regulatory Affairs team, allocate responsibilities, and ensure timely completion of submissions and regulatory activities.
7. Coordinate with internal stakeholders and third-party/contract manufacturing partners to resolve regulatory and submission-related delays.
8. Manage product lifecycle activities, including renewals, variations, post-approval changes, change controls, and regulatory filings, ensuring product continuity.
9. Review and approve regulatory aspects of change controls and ensure timely filing and approval of variations across ROW markets.
10. Manage regulatory activities including regulatory updates, NDC, drug listing, dossier compilation, filing/submission, query responses, CARES Act requirements, and coordination of pharmacovigilance activities.
11. Ensure continued product compliance with approved dossiers, applicable regulations, and regulatory commitments.
12. Review, provide comments, and ensure closure of QMS documents, including Change Controls, Deviations, Incidents, and CAPAs in 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 updates based on PRAC recommendations and other applicable regulatory authority requirements.
16. Track regulatory changes and assess their impact on existing products, dossiers, and submission strategies.
17. Establish effective coordination with Quality, R&D, Clinical, Pharmacovigilance, Manufacturing, Supply Chain, and other cross-functional teams to ensure regulatory compliance and business continuity.
18. Drive continuous improvement of regulatory processes, submission quality, compliance, and overall regulatory readiness.

Desired Competencies

• Strong knowledge of regulatory requirements and submission processes for ROW markets.
• Expertise in dossier review, lifecycle management, variations, renewals, and regulatory submissions.
• Strong understanding of regulatory compliance, QMS, pharmacovigilance coordination, and post-approval requirements.
• Excellent team management, stakeholder coordination, communication, and problem-solving skills.
• Ability to manage multiple regulatory projects and submissions within defined timelines.