Senior Regulatory Manager

Hetero Healthcare Limited; Hyderabad; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Hetero Healthcare Limited is seeking a seasoned AGM/Senior Manager Regulatory Affairs to lead corporate regulatory activities across units and portfolios. You will shape regulatory strategies, oversee dossier preparation, submissions, and lifecycle management, while guiding cross-functional teams to support growth in international markets.

You will align regulatory plans with business objectives, manage authority interactions, and mentor a team to deliver compliant, timely registrations and

Qualifications

• Minimum 18 years of experience in Pharmaceutical Regulatory Affairs.
• Strong experience in international registrations, dossier preparation and review, regulatory submissions, and lifecycle management.
• Experience coordinating with manufacturing sites and cross-functional departments.
• Prior corporate regulatory affairs and team leadership experience preferred.

Responsibilities

• Corporate Regulatory Strategy: Develop regulatory strategies for new product registrations, lifecycle management, renewals, variations, and post‑approval changes.
• International Product Registration: Manage product registrations across EU, SEA, LATAM, Africa, CIS, MENA and other regulated and emerging markets.
• Dossier Management: Review and approve CTD/eCTD, ACTD, and country-specific dossiers, ensuring completeness and compliance with applicable requirements.
• Regulatory Compliance: Monitor country-specific regulations, assess regulatory pathways, and support new-market feasibility assessments.
• Regulatory Authority Interactions: Coordinate responses to deficiency letters, assessment reports, clarification requests, and regulatory commitments.
• Product Lifecycle Management: Manage renewals, variations, manufacturing-site changes, process and formulation changes, packaging changes, shelf-life extensions, and technology transfers.
• Corporate Regulatory Planning: Maintain submission plans, trackers, dashboards, approval status reports, and management review presentations.
• Business Development Support: Provide regulatory feasibility assessments for new products and markets, including RLD, BE, stability, and registration requirements.
• Cross-Functional Coordination: Coordinate with Plant QA/RA, FR&D, AR&D, QC, Manufacturing, Supply Chain, and Business Development.
• Regulatory Intelligence: Monitor global regulatory guidelines, pharmacopeial requirements, GMP expectations, and country-specific regulatory updates.
• Team Leadership: Lead and mentor the Regulatory Affairs team, allocate responsibilities, monitor performance, and establish SOPs and corporate governance systems.
• Regulatory Documentation: Maintain regulatory approvals, certificates, correspondence, commitments, and submission archives in compliance with company procedures.
• Management Reporting: Prepare MIS reports, regulatory dashboards, pending query reports, and updates on risks, opportunities, delays, and resource requirements.

Skills

CTD/eCTD knowledge

Regulatory strategy

Dossier review

Regulatory submissions

Deficiency management

Stakeholder management

Education

B.Pharm / M.Pharm / Pharm.D

Postgraduate qualification in Regulatory Affairs

Tools

MS Excel

PowerPoint

Regulatory trackers

Management reporting

Job description

Role & responsibilities

Job Role

To lead and manage corporate regulatory affairs activities across manufacturing units and product portfolios, ensuring timely product registrations, regulatory compliance, lifecycle management, and international market expansion. The role involves developing regulatory strategies, overseeing dossier preparation and submissions, coordinating cross-functional teams, managing regulatory authority interactions, and providing strategic regulatory guidance to support business growth.

Key Responsibilities

1. Corporate Regulatory Strategy: Develop regulatory strategies for new product registrations, lifecycle management, renewals, variations, and post-approval changes.
2. International Product Registration: Manage product registrations across EU ,SEA, LATAM, Africa, CIS, MENA and other regulated and emerging markets.
3. Dossier Management: Review and approve CTD/eCTD, ACTD, and country-specific dossiers, ensuring completeness and compliance with applicable requirements.
4. Regulatory Compliance: Monitor country-specific regulations, assess regulatory pathways, and support new-market feasibility assessments.
5. Regulatory Authority Interactions: Coordinate responses to deficiency letters, assessment reports, clarification requests, and regulatory commitments.
6. Product Lifecycle Management: Manage renewals, variations, manufacturing-site changes, process and formulation changes, packaging changes, shelf-life extensions, and technology transfers.
7. Corporate Regulatory Planning: Maintain submission plans, trackers, dashboards, approval status reports, and management review presentations.
8. Business Development Support: Provide regulatory feasibility assessments for new products and markets, including RLD, BE, stability, and registration requirements.
9. Cross-Functional Coordination: Coordinate with Plant QA/RA, FR&D, AR&D, QC, Manufacturing, Supply Chain, and Business Development.
10. Regulatory Intelligence: Monitor global regulatory guidelines, pharmacopeial requirements, GMP expectations, and country-specific regulatory updates.
11. Team Leadership: Lead and mentor the Regulatory Affairs team, allocate responsibilities, monitor performance, and establish SOPs and corporate governance systems.
12. Regulatory Documentation: Maintain regulatory approvals, certificates, correspondence, commitments, and submission archives in compliance with company procedures.
13. Management Reporting: Prepare MIS reports, regulatory dashboards, pending query reports, and updates on risks, opportunities, delays, and resource requirements.

Educational Qualification

• B.Pharm / M.Pharm / Pharm.D or equivalent qualification in Pharmaceutical Sciences.
• A postgraduate qualification in Regulatory Affairs will be an added advantage.

Experience

• Minimum 18 years of experience in Pharmaceutical Regulatory Affairs.
• Strong experience in international registrations, dossier preparation and review, regulatory submissions, and lifecycle management.
• Experience coordinating with manufacturing sites and cross-functional departments.
• Prior corporate regulatory affairs and team leadership experience preferred.

Key Performance Indicators (KPIs)

• Timely dossier submissions and product registration approvals.
• Quality and accuracy of regulatory submissions.
• Timely responses to regulatory authority queries.
• On‑time completion of renewals, variations, and commitments.
• Effective cross‑functional coordination and regulatory risk management.
• Accuracy of management reports and regulatory dashboards.
• Team performance and implementation of regulatory governance systems.

Overall Role Expectation

The AGM / Senior Manager Regulatory Affairs will lead corporate regulatory activities, strengthen regulatory compliance across manufacturing units, facilitate international market expansion, and support business objectives through effective regulatory planning, dossier governance, and cross‑functional leadership.

Preferred candidate profile

Required Skills

• Strong knowledge of CTD/eCTD, ACTD, and country‑specific registration requirements.
• Understanding of global regulatory guidelines, GMP, and pharmaceutical quality systems.
• Expertise in regulatory strategy, dossier review, deficiency management, variations, and renewals.
• Strong communication, analytical, planning, and stakeholder management skills.
• Proficiency in MS Excel, PowerPoint, regulatory trackers, and management reporting.
• Ability to manage multiple submissions, priorities, and deadlines.