Deepak Kumar
Regulatory Affairs (CMC, Publishing & Submissions)-European Union
- Role
- Regulatory Affairs Manager at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Deepak Kumar
Skilled in Research, Management, Microsoft Office, Pharmaceutical Industry,Formulation…
Experience
Regulatory Affairs Manager
Apr 2025 — Present · Bengaluru, IN
Led the development, due-diligence, execution, and maintenance of submission delivery plans and submission content plans. Leveraged and shared regulatory best practices in interactions with health authorities and in daily workflow, optimizing efficiency and compliance within a fast-paced environment. Preparation of 1572 forms for FDA submission.Reviewing the submission as per the regulatory standards and creating primary events and events for variations and documents upload and data entry into CTIS and submit application via CTIS.Served as a mentor and coach within the RAM skill group, actively promoting knowledge transfer and professional development. Contributed to process improvement by proactively identifying, managing, escalating, and resolving issues on submissions. Archive the notifications, RAQ\'s, POS, POP and update project status and hyperlink with project tracker in a timely manner
Education
Alameen College Of Pharmacy,Bangalore
Masters in Pharmacy, M-PHARM
2016 — 2018
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.