Senior Regulatory Affairs Officer

2 weeks ago

Ahmedabad, Gujarat, India Medi Pharma Konnect Full time ₹ 12,00,000 - ₹ 36,00,000 per year

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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