Deep Dutta
Global Regulatory Affairs | Product Development | Project Management | Product Life Cycle Management | Pharma Product Manager
- Role
- Regulatory Affairs Manager at AstraZeneca
- Location
- Bengaluru, KA, IN
- LinkedIn followers
- 500 followers
About Deep Dutta
Regulatory Affairs professional with 13+ years of experience in CMC regulatory strategy, dossier authoring, and lifecycle management across global pharmaceutical markets. I specialize in developing effective regulatory strategies, preparing high-quality submissions, and driving cross-functional collaboration to support successful product development and commercialization.Throughout my career, I have contributed to a wide range of regulatory activities including product development, New Drug Applications (NDA), Marketing Authorization Applications (MAA), asset migrations, legal entity name changes, gap assessments, and regulatory dossier authoring. I bring strong experience working with regulatory information management and submission tools used for authoring, review, and lifecycle maintenance.I have extensive exposure to major regulated markets including the US and EU, as well as other international markets. My work involves coordinating and executing regulatory strategies while collaborating with cross-functional teams and global stakeholders to ensure timely and compliant submissions.Currently, I act as a product owner for new and commercial products. In this role, I oversee global CMC regulatory strategies and submissions, ensuring that regulatory activities and documentation meet required standards across the product lifecycle. I lead and contribute to regulatory CMC aspects of projects, maintain clear communication with project teams and stakeholders on timelines and regulatory commitments, and support team development by mentoring new colleagues and helping them ramp up on project deliverables.
Experience
Regulatory Affairs Manager
Dec 2023 — Present · Bengaluru, IN
Education
St. Mary's School
High School
1991 — 2004
Amravati University
Master's Degree, Pharmacy
2011 — 2013
Digboi College
12th Standard, Science
2004 — 2006
Amravati University
Bachelor's Degree, Pharmacy
2007 — 2011
Skills
- Variation in Europe
- Amendment in Us
- Technology Transfer
- Active Substance Master File (Asmf)
- Hplc
- Standard Operating Procedure (Sop)
- Analytical Method Validation
- Dissolution
- Regulatory Affairs
- Annual Report for Us
- Drug Master File
- Certificate of Suitability (Cep)
- Anda
- Dissolution Testing
- Sop
- Annual Notification for Europe
- Gmp
- Analytical Method Developmet
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