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Senior Regulatory Affairs Executive
White Force GroupAhmedabad, Gujarat, India1 day ago
Job descriptionRegulatory Strategy & Market Compliance : Develop and execute regulatory strategies for product Bioequivalence Studies & Compliance : Ensure compliance with bioequivalence study requirements for Product Lifecycle Management : Manage regulatory aspects throughout the product lifecycle, including Product Registration & Market Expansion : Handle product registration processes, liaising with Technical File Review : Ensure accuracy and completeness of technical files for regulatory submissions. Regulatory Compliance & Audits : Monitor and ensure compliance with country-specific regulatory Regulatory Documentation & Reporting : Maintain up-to-date regulatory documentation and provide Stakeholder Management : Serve as the primary liaison between regulatory agencies, internal teams, Process Improvement & Team Leadership : Implement process improvements, mentor junior regulatory
CTC - 8 Lpa
Exp - 5+ years
Your Key Responsibilities
- Dossier Preparation & Compilation : Lead and oversee the preparation, review, and submission of
regulatory dossiers in CTD, ACTD, and eCTD formats for global markets, ensuring compliance with
country-specific guidelines.
approvals in the ROW, LATAM, SEA, Africa, and Pacific regions.
international submissions and coordinate with CROs for study approvals.
renewals, variations, and post-marketing compliance.
regulatory authorities and ensuring smooth approvals in targeted markets.
guidelines, including WHO-GMP, ICH, and other applicable standards.
periodic reports to senior management.
and external partners to facilitate submissions and approvals.
staff, and drive efficiency in regulatory operations.
9109472707
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Senior Executive • Ahmedabad, Gujarat, India
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