Mukul Mehta
Regulatory Affairs Professional | Medical Devices & Biopharma | Global Compliance & Licensing Expert
- Role
- Assistant Manager at Avantor
- Location
- Gurugram, HR, IN
- LinkedIn followers
- 500 followers
About Mukul Mehta
Experienced Regulatory Affairs Specialist with 9+ years of expertise in securing…
Experience
Assistant Manager
Feb 2022 — Present · Gurugram, IN
Ensuring business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.• Coordinates with Source Company and prepares document packages for regulatory submissions from all areas (Medical Devices & In vitro diagnostics, Drugs & Biological) of different franchisee of company.Keeps abreast of regulatory procedures and changes & regular direct interaction with regulatory agencies (DCGI, Drug Controllers Office, State FDA, ADC Airport & NIB, Noida) on defined matters.• Interacting with Marketing & Sales, R&D, Supply Chain & Finance department with respect to product, amendments in product specifications or manufacturing, packaging, manufacturing location, etc & provide regulatory support as and when required.• Actively making available all required documents/certificates for filing of tenders against the tender request from across all over the Indian market & other countries.• Maintaining the registration database & ensuring the regulatory compliance.Provide post market support to country management team eg. Approving & ensuring local country MRP labeling prior to custom clearance and before placing the product into the Indian market.• Timely reporting of adverse events/reports/product recalls notification letter to regulatory agency.• Review and approve Advertising and Promotional materials for all products to ensure regulatory compliance.• Monitor regulatory and compliance development within country and provide management with assessment of impact of changing or new upcoming regulations on businesses.
Education
Panjab University
Master of Pharmacy (M.Pharm.), Pharmacy
2014 — 2016
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.