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Medi Pharma Konnect
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Senior Regulatory Affairs Officer

Senior Regulatory Affairs Officer

Medi Pharma Konnect

6 - 10 years

6 Lacs

Ahmedabad

Posted:4 days ago| Platform:

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Skills Required

Regulatory Affairs management Market Compliance Product Registration Product Lifecycle Management Regulatory Documentation Regulatory Compliance

Work Mode

Work from Office

Job Type

Full Time

Job Description

Dossier Preparation & Compilation:
Lead the preparation, review, and submission of regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring adherence to country-specific regulations.Regulatory Strategy & Market Compliance:Develop and implement regulatory strategies for product approvals across ROW, LATAM, SEA, Africa, and Pacific regions.Bioequivalence Studies & Compliance:Coordinate with CROs to ensure compliance and timely approval of bioequivalence studies for international submissions.Product Lifecycle Management:Oversee regulatory activities throughout the product lifecycle including renewals, variations, and post-marketing compliance.Product Registration & Market Expansion:Handle product registration processes, liaise with authorities, and ensure smooth approvals in targeted regions.Technical File Review:Review technical documentation to ensure accuracy and completeness for regulatory filings.Regulatory Compliance & Audits:Ensure compliance with country-specific guidelines including WHO-GMP, ICH, and other global standards.Regulatory Documentation & Reporting:Maintain accurate and updated regulatory records and provide timely reports to senior leadership.Stakeholder Management:Act as the key liaison between regulatory bodies, internal departments, and external partners.Process Improvement & Team Leadership:Mentor junior team memb

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Senior Regulatory Affairs Officer