Swati Mishra

Assistant Manager Regulatory Affairs @MSD

Gurugram, IN

Manage the timely submission and follow-up of labeling and quality-related variations,ensuring coordination with key stakeholders (worldwide product labeling, CMC, HQ, andregional regulatory teams). Hands-on experience in product registration and import license filings alongwith renewals and Post Approval Change applications, ensuring compliance with regulatoryrequirements. Experience of performing activities in Veeva RIMS. Experience in handling small molecules and vaccines portfolio. Lead the renewal process in collaboration with CMC, HQ, and regional regulatory teams,ensuring timely preparation, submission, and approval of renewal files. Provide efficient regulatory input for packaging and label components, ensuring timelyimplementation of artwork for India and coordination with local artists. Responsible for maintaining regulatory compliance for Critical Care products, ensuringalignment with relevant legislation and internal procedures. Monitor and document all regulatory actions to ensure adherence to compliance metricssuch as Artwork and E2E labeling compliance.

Kendriya Vidyalaya

School

Ramanand Institute of Pharmacy Management & Technology

Bachelor of Pharmacy

Indira Gandhi National Open University (IGNOU)

PG Diploma in Intellectual Property Rights (PGDIPR)

Banasthali Vidyapith

Master of Pharmacy