Senior Manager Regulatory Affairs

Acme Generics; Solan; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Acme Generics Pvt. Ltd. in India seeks a Regulatory Affairs professional to lead regulatory submissions, ensure dossier compliance across US, EU, ROW and emerging markets, and coordinate with cross-functional teams.

Responsibilities include managing bioequivalence discussions, handling variations and post-approval changes, and providing guidance on pre- and post-approval activities to maintain product approvals and market access in a fast-paced environment.

Responsibilities

• Review regulatory dossiers and ensure compliance with US, EU, ROW & Emerging markets.
• Coordinate with authorities and internal stakeholders on bioequivalence and active ingredient levels.
• Lead and manage the Regulatory Affairs team and monitor submission timelines.
• Oversee product lifecycle activities including variations, renewals, and post-approval changes.
• Ensure timely responses to deficiencies, queries, and information requests.
• Drive continuous improvement in regulatory processes and submission quality.

Job description

• 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.
• Ensure the consistency, completeness, accuracy, and adequacy of regulatory submissions in line with applicable regulations and regulatory authority expectations.
• Provide regulatory guidance for pre-approval and post-approval activities, including submissions, approvals, and management of regulatory commitments.
• Coordinate with regulatory authorities and internal stakeholders on bioequivalence requirements, regulatory recommendations, and inactive ingredient levels during product development.
• Ensure timely preparation and submission of responses to regulatory deficiencies, queries, and requests for additional information.
• Lead and manage the Regulatory Affairs team, allocate responsibilities, monitor performance, and ensure timely execution of submissions and regulatory activities.
• Coordinate with internal stakeholders, third-party manufacturers, and contract manufacturing partners to resolve regulatory issues and submission-related delays.
• Manage product lifecycle activities, including renewals, variations, post-approval changes, change controls, and regulatory filings, to ensure continued product availability and compliance.
• Review and approve the regulatory aspects of change controls and ensure timely filing and approval of variations across applicable markets.
• 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.
• Ensure continued product compliance with approved dossiers, applicable regulatory requirements, and regulatory commitments.
• Review, provide regulatory inputs on, and ensure timely closure of QMS documentation, including Change Controls, Deviations, Incidents, and CAPAs in the 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 (Reference Safety Information) updates in accordance with PRAC recommendations and other applicable regulatory authority requirements.
• Monitor regulatory updates and assess their impact on existing products, approved dossiers, product lifecycle activities, and submission strategies.
• Collaborate with Quality Assurance, R&D, Clinical, Pharmacovigilance, Manufacturing, Supply Chain, and other cross-functional teams to ensure regulatory compliance and business continuity.
• Drive continuous improvement in regulatory processes, submission quality, compliance practices, and overall regulatory readiness.