- 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:
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Lead regulatory strategy, due diligence, and compliance activities for international markets.
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Manage product registrations, renewals, variations, and regulatory submissions within timelines.
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Review dossiers, tender documents, labeling, and compliance-related documentation.
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Develop regulatory strategies supporting product development, commercialization, and lifecycle management.
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Monitor global regulatory changes and provide strategic recommendations to stakeholders.
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Collaborate with cross-functional teams to ensure successful product launches and market expansion.
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Liaise with health authorities, distributors, partners, and consultants for regulatory matters.
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Manage regulatory inspections, audits, GMP interactions, and compliance requirements.
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Resolve regulatory queries, deficiencies, and compliance risks through stakeholder coordination.
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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
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