CORONA Remedies Limited is the Fastest Crowing Pharmaceutical organization based in Ahmedabad, India. We offer the finest working culture. Our "Care for Coronates" is an industry-known concept that has helped us foster a family of growing individuals. We are proud to share that we are 5000+ Coronates; going not just beyond growth but turning ourselves into a force to reckon with.
Post : Regulatory Affairs Manager / Sr. Manager
JOB SUMMARY
• Lead regulatory due diligence and manage global product registrations, renewals, variations, and other regulatory submissions in compliance with timelines.
• Oversee technical evaluation of dossiers, deficiency responses, labeling, and post-marketing reports to ensure accuracy and regulatory compliance.
• Develop and implement regulatory strategies supporting product development, registration, lifecycle management, and business objectives.
• Monitor regulatory changes, assess impact, and provide strategic recommendations to stakeholders and senior management.
• Collaborate with cross-functional teams to ensure timely product launches, uninterrupted supply, and market expansion.
• Liaise with health authorities, partners, affiliates, and consultants for timely exchange of regulatory information.
• Act as primary regulatory contact for authorities and manage correspondence, inspections, audits, and GMP interactions.
• Drive timely resolution of queries and compliance gaps through effective coordination and risk-based decision-making.
• Track compliance metrics, identify risks and opportunities, and present actionable insights in management reviews.
• Support regulatory intelligence and stay updated on global trends and best practices.
• Provide leadership, mentoring, and guidance to the regulatory team to ensure capability development and high standards.
REQUIRED SKILLS
• Regulatory Strategy & Compliance Management
• Regulatory Intelligence & Risk Assessment
• Global Product Registration & Lifecycle Management
• Cross-Functional Stakeholder Management
• Health Authority Interactions
Qualification : M.Pharm/ B.Pharm/ M.Sc
Experience required : 10 to 15 Years
Job Location : CORONA Remedies Limited - Head Office
Mondeal Business Park, Near Gurudwara, S.G. Highway, Ahmedabad
Regulatory Affairs Manager : Apply here
See All B.Pharm Alerts M.Pharm Alerts M.Sc Alerts Ahmedabad Alerts
See All Other Jobs in our Database
Subscribe to Pharmatutor Job Alerts by Email
