Role & responsibilities -
Review, preparation and finalize all CTD submissions for ROW/ EMERGING markets. Target to submit dossiers every month
Coordinate with R&D; for the registration of current formulations (Solids/Liquids/Creams)
Provide regulatory support to internal teams, global stakeholders, and external clients across multiple projects.
Develop regulatory strategies for recent product introductions and third-party vendor submissions.
Manage lifecycle activities including post-approval variations, renewals, and regulatory queries.
Collaborate cross-functionally with QA, QC, Packaging, and Production to ensure regulatory alignment.
Standardize and author SOPs, secured DMF/ASMF and BE/BA data, and support vendor qualification and training processes.
Liaison with local consultants and health authorities for faster approvals.
Conduct regulatory risk assessments for changes in manufacturing sites/vendors.
Oversee trademark filing and prosecution process, including coordination with external legal consultants and final approval of applications before submission.
Mentor and overlook daily technical output of Executives and Trainees.

📌 Job Opportunity At Meyer Vitabiotics For Regulatory Affair Manager Thane
🏢 Meyer Organics
📍 Thane