Samuel Mboggo
Associate Director Regulatory Affairs @BridgeBio
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WORK HISTORY
Associate Director Regulatory Affairs @BridgeBio
Palo Alto, CA, US
Serve as a global regulatory lead for ongoing Phase 2/3 clinical trials (encaleret) for IND in the US & CTA\'s in Canada, Brazil, EU, Japan, and the UK for Calcilytix, a BridgeBio subsidiary in the cardio-renal area. • Represent regulatory on the cross-functional team(s) in the development, preparation, and implementation of regulatory strategies for assigned programs.•Support the preparation of NDA/MAA by preparing Module 3 drug product and drug substance sections, and by preparing Module 1 regional docs (including labeling) for both the US (NDA) and the EU (MAA). • Proactively identify program issues and implement appropriate regulatory strategies to mitigate risks. • Provide strategic guidance and review of regional regulatory documents for various submissions and other relevant regulatory filings. • Leads agency meeting preparation and attends key agency meetings to ensure full discussion of issues and opportunities and to track critical outcomes and commitments. • Provides guidance to all appropriate departments to assure regulatory compliance with applicable regulations, remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel. • Supports development, review, and maintenance of Regulatory policies and SOPs.
EDUCATION
Regulatory Affairs Professionals Society (RAPS) University
Regulatory Affairs Certificate Program, Pharmaceuticals
Ilboru Secondary School, Arusha
High School
Irvine Valley College
Associate's Degree, Biochemistry and Molecular Biology
California State Polytechnic University-Pomona
Bachelor's Degree, B.S. Biotechnology
SKILLS
ABOUT SAMUEL MBOGGO
Biopharmaceutical regulatory affairs professional with experience working with multiple therapeutic areas at world-class bio-therapeutics companies such as Amgen, Atara Biotherapeutics and BridgeBio Pharma.•Proven ability to manage time effectively, take on complex assignments and collaborate with colleagues on a global level. •Demonstrated analytical and communication skills that encompass identifying, solving, and presenting challenging ideas in a clear, persuasive manner.•Eager to contribute in a challenging biotech career where a combination of education and experience in regulatory affairs, biochemistry, and pharmaceutics can meet patients\' needs.
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