Sravan Kumar Reddy P.
Submission Manager at Novartis
- Role
- Submission Manager at Novartis
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Sravan Kumar Reddy P.
Regulatory Affairs professional with 10 years of experience driving global regulatory strategy and managing complex submissions including initial INDs/CTAs, NDAs/BLAs/MAAs, Type II variations/supplements and life-cycle management across US, EU and international (ROW) markets.Adept at leading cross-functional teams, facilitating strategic meetings, and aligning stakeholders on submission strategy, labeling, and key clinical messages to meet critical submission deadlines.Core Competencies:* Global Regulatory Strategy* Cross-functional Team Leadership* Global Labeling Management (CCDS, EU SmPC and US PI)* Lifecycle Management & Compliance* Risk Identification & Mitigation* Process Optimization* Mentorship & Team Development
Experience
Submission Manager
Sep 2024 — Present
Lead global submission planning for medium-to-high complex regulatory filings, including initial marketing applications, product line extensions, renewals, label updates, and supplements.• Identify and track all clinical submission deliverables (Module 1, 2 & 5) by negotiating timelines, assigning responsibilities, and maintaining real-time updates in submission trackers.• Facilitate strategic cross-functional meetings (e.g, Clinical Submission Team, Data Analysis Review, Key Message Harmonization, Clinical Summary Document Review) to align on submission strategy, target labeling, and key efficacy, safety, biopharmaceutics, and clinical pharmacology messages.• Contribute to pre-submission Health Authority briefing books.• Proactively assess and mitigate risks or strategy shifts impacting submission timelines or content.• Author and review eCTD modules (1.3.4, 1.4.3, 1.9, 2.7.5, 2.7.6, 5.2, 5.3.7), ensuring compliance with ICH and local HA requirements.• Mentor junior submission managers to ensure consistent delivery of high-quality, right first-time submissions.• Veeva Vault SME, driving process improvements and enhancing document management efficiency.
Education
Chinmaya Vidyalaya, Begumpet, Hyderabad
High School, Mathematics, Physics, Chemistry and Biology
2008 — 2010
Manipal College of Pharmaceutical Sciences
Doctor of Pharmacy (Pharm. D), Pharmaceutical Sciences
2010 — 2016
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