Trishla Bheda
Regulatory Affairs - Regulated Market US, EU, UK, Australia & NZ
- Role
- Regulatory Affairs Manager at Swati
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Trishla Bheda
Regulatory Affairs domain with over 8+ years of experience in regulatory strategy…
Experience
Regulatory Affairs Manager
May 2019 — Present · Mumbai, IN
Lead the preparation and submission of dossiers – ACTD,CTD and e-CTD for ROW,Semi-Regulated and Regulated market ensuring submission as per target timelines.• Develop regulatory strategies for new and existing products to meet global regulatory requirements.• Liaise with FDA,EMA and other regulatory agencies to facilitate product approvals and resolve regulatory issues.• Manage cross-functional teams to ensure regulatory requirements are met throughout the product lifecycle.• Monitor updates for product renewals, review and approve labelling, changes in regulatory guidelines and implement necessary updates to company procedures and documentation.• Mentorship to juniors on veterinary products registration procedures and filing.• Identify potential leads/companies in Latam, Europe, Asia, Africa and Gulf countries for registration requirements.•Co-ordinate with manufacturers for impurities & excipients pricing, vendor qualification and other supporting documents required for vendor approval.
Education
INSTITUTE OF CLINICAL RESEARCH INDIA
PG Diploma in Clinical Reasearch
University of Mumbai
Bachelor's degree in Chemistry
SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master's degree
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