Senior Regulatory Affairs Manager

JOB DESCRIPTION

Sr Manager- Regulatory Affairs (ROW)

Key Responsibilities

• Review registration dossiers in coordination with technical functions and in/out-licensing partners to ensure compliance with current regulatory requirements of ROW markets.
• Ensure consistency, completeness, and adequacy of regulatory submissions in line with applicable regulations and agency expectations.
• Provide strategic regulatory guidance for pre-approval and post-approval activities, including submissions, approvals, and regulatory commitments.
• Coordinate with regulatory authorities on bioequivalence requirements, recommendations, and inactive ingredient levels during product development.
• Ensure timely preparation and submission of responses to regulatory deficiencies and queries.
• Lead and manage the Regulatory Affairs team, allocate responsibilities, and ensure timely completion of submissions and regulatory activities.
• Coordinate with internal stakeholders and third-party/contract manufacturing partners to resolve regulatory and submission-related delays.
• Manage product lifecycle activities, including renewals, variations, post-approval changes, change controls, and regulatory filings, ensuring product continuity.
• Review and approve regulatory aspects of change controls and ensure timely filing and approval of variations across ROW markets.
• Manage regulatory activities including regulatory updates, NDC, drug listing, dossier compilation, filing/submission, query responses, CARES Act requirements, and coordination of pharmacovigilance activities.
• Ensure continued product compliance with approved dossiers, applicable regulations, and regulatory commitments.
• Review, provide comments, and ensure closure of QMS documents, including Change Controls, Deviations, Incidents, and CAPAs in EQMS.
• Ensure timely and effective execution of regulatory-related activities in ERP, LIMS, eLog, AMS, and LMS systems.
• Coordinate and deliver regulatory training programs through the Learning Management System (LMS).
• Monitor and manage RSI updates based on PRAC recommendations and other applicable regulatory authority requirements.
• Track regulatory changes and assess their impact on existing products, dossiers, and submission strategies.
• Establish effective coordination with Quality, R&D, Clinical, Pharmacovigilance, Manufacturing, Supply Chain, and other cross-functional teams to ensure regulatory compliance and business continuity.
• 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.