Daniel Galla
Associate Director, Regulatory Affairs, Cencora Global Consulting Services
- Role
- Associate Director, Regulatory Affair and Strategic Product Development at Cencora
- Location
- Jersey City, NJ, US
- LinkedIn followers
- 500 followers
Experience
Associate Director, Regulatory Affair and Strategic Product Development
Sep 2023 — Present
Serve as regulatory lead across various development programs (including oncology), providing strategic and operational guidance on regulatory development and submission activities.• Lead FDA meetings and prepare briefing documents (Types A, B, C and D), including EOP1/2 and Pre-NDA strategy planning.• Develop and manage regulatory strategies including contribution to TPPs, CDPs, and risk assessments to ensure timely progression of global oncology development programs.• Program management activities for larger multi-discipline team to support and lead IND, ANDAs, NDAs and BLAs, preparation, submission and risk mitigations.• Key contribution on global development strategies, including driving US development execution.
Skills
- Project Management
- Pharmaceutics
- Life Sciences
- Molecular Biology
- Regulatory Compliance
- Gene Expression
- Regulatory Submissions
- Cmc Regulatory Affairs
- Quality Assurance
- Change Control
- Regulatory Requirements
- Biochemistry
- Gmp
- Cell Culture
- Regulatory Affairs
- Regulatory Intelligence
- Ich Guidelines
- Biotechnology
- Rt-Pcr
- Pharmaceutical Industry
- Sop
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