The Role
Leads global regulatory strategy and compliance across international markets, including product registrations, renewals, variations, submissions, dossier and labeling reviews, health authority interactions, inspections, audits, and GMP activities. Coordinates cross-functional stakeholders to support product launches and lifecycle management, resolves regulatory deficiencies, monitors regulatory changes, manages compliance risks, and mentors regulatory team members.
Summary Generated by Built In
- Position: Manager/ Sr. Manager - Regulatory Affairs
- Job Location: Corporate Office, Ahmedabad
- Experience required: 10 – 15 Years
- Qualification: ,M.Pharm/ B.Pharm/ M.Sc
Job Summary:
• Lead regulatory strategy, due diligence, and compliance activities for international markets.
• Manage product registrations, renewals, variations, and regulatory submissions within timelines.
• Review dossiers, tender documents, labeling, and compliance-related documentation.
• Develop regulatory strategies supporting product development, commercialization, and lifecycle management.
• Monitor global regulatory changes and provide strategic recommendations to stakeholders.
• Collaborate with cross-functional teams to ensure successful product launches and market expansion.
• Liaise with health authorities, distributors, partners, and consultants for regulatory matters.
• Manage regulatory inspections, audits, GMP interactions, and compliance requirements.
• Resolve regulatory queries, deficiencies, and compliance risks through stakeholder coordination.
• Mentor regulatory team members and drive continuous improvement through regulatory intelligence and best practices.
Required Skills:
> Regulatory Strategy & Compliance Management
> Global Product Registration & Lifecycle Management
> Health Authority Interactions
> Regulatory Intelligence & Risk Assessment
> Cross-Functional Stakeholder Management
> Technical Dossier Review & Submission Management
> Good communication
> Ownership
Skills Required
- 10–15 years of relevant experience
- M.Pharm, B.Pharm, or M.Sc qualification
- Regulatory strategy and compliance management experience
- Global product registration and lifecycle management experience
- Health authority interaction experience
- Regulatory intelligence and risk assessment skills
- Cross-functional stakeholder management skills
- Technical dossier review and submission management experience
- Good communication skills
- Ownership and accountability
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The Company
What We Do
CORONA Remedies Limited is an Ahmedabad-based pharmaceutical company founded in 2004. It develops, manufactures, and commercialises innovative, value-added, evidence-based medicines addressing unmet health needs. Its portfolio focuses on chronic-care and specialty therapeutic areas, including women’s healthcare and pain management. The company operates manufacturing facilities in Gujarat and Himachal Pradesh and aims to improve health outcomes through quality products and research.
