Key responsibilities:
Ensuring the dossiers are prepared and submitted for both local and export product registration.
Verify the quality, correctness, and completeness of regulatory submissions.
Managing the DCGI and FDA regulations locally.
Make sure that all product artwork is submitted in the appropriate format, changed as needed, and that any subsequently approved artwork is appropriately documented and shared.
To support compliance, make sure that all regulatory submissions, correspondence with authorities, and final approval are accurately recorded and communicated.
Ensuring prompt and accurate answers to inquiries from clients, both internal and external.
Completing any work assigned by the export manager that helps with the day-to-day operations of the export department and supporting the export manager's marketing and business development initiatives.
Take part in career-development training programs to become highly competent in all facets of regulatory affairs.
Regulatory life cycle management
Dossier preparation and compilation for semi regulated markets-Afreica/Asia/LATAM
Interested candidates can apply by sharing their CV on maitrivakil@unisonpharmaceuticals.com
In 1981, Unison Pharmaceuticals Private Limited (formerly Unison Pharmaceuticals) was founded with the goal of supplying high-quality, cost-effective medications throughout the country. Unison has provided society with medical care for four decades and is currently one of Gujarat State's fastest growing businesses. The corporation has a highly solid position in the market because its base of operations is just one state. Throughout all aspects of corporate operations, the corporation strictly upholds moral principles and ethical standards.