Curriculum Vitae
Jeremy Jakob
Executive Summary
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Senior Pharma Regulatory Affairs and CMC strategist with 18+ years of proven expertise in global regulatory project management, specializing in complex submissions (IND, IMPD, BLA, MAA, DMF) through integrated RA-QA-QC-TechOps collaboration.
Unique expertise in ADCs, monoclonal antibodies, peptides with cross-functional team leadership delivering accelerated approvals.
ROI-focused approach with demonstrated track record of seamless tech transfers, zero compliance issues, and cost optimization across EU, US, Japan, and emerging markets.
Professional Experience
Feb 2025 - Present
Independent Principal RA CMC Stategist, Switzerland
​​International Multi-Client Engagements
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Strategic Leadership: Drive complex development programs across EMA, FDA, Health Canada, and RoW regions
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Cross-Functional Excellence: Orchestrate seamless collaboration between RA, QA, QC, and Tech Ops for integrated CMC strategies
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Technical Excellence: Coordinate eCTD documentation (Modules 2.3, 3.2.S, 3.2.P) with QA/QC input validation and Tech Ops feasibility assessment
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Process Optimization: Implement digital RA solutions bridging regulatory requirements with operational capabilities​​​​​​
Aug 2021 - Feb 2025
Novartis AG, Basel, Switzerland
​Associate Director RA CMC, Biologics
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Cross-Functional Leadership: Built integrated RA-QA-QC-TechOps matrix teams for critical product portfolio management
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Quality Integration: Pioneered joint RA-QA review processes, reducing regulatory query cycles through proactive quality alignment
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Tech Ops Partnership: Co-developed manufacturing change control procedures with Tech Ops, ensuring regulatory compliance during scale-up and transfers
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Digital Innovation: Spearheaded Veeva Suite implementation with QA/QC workflow integration for real-time collaboration
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Authority Relations: Led joint RA-QA delegations to EMA, FDA, and Health Canada for technical discussions and GMP inspections
Nov 2013 - Aug 2021
Lonza AG, Basel, Switzerland
Senior Regulatory Affairs Manager
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Cross-Functional Excellence: Established RA-QA-TechOps Centers of Excellence for ADCs, biologics, and peptides manufacturing
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Quality Partnership: Co-authored QA-RA SOPs for deviation investigations, reducing regulatory impact assessments timeframes
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Tech Transfer Leadership: Led joint RA-TechOps teams for successful site transfers with zero regulatory delays
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Business Transformation: Converted RA from cost center to integrated service hub generating revenue through QA-TechOps collaboration
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Process Innovation: Implemented Veeva-integrated QMS connecting RA submissions with QA batch records and Tech Ops data
Feb 2010 - Nov 2013
Tillotts Pharma AG, Rheinfelden, Switzerland
Regulatory Affairs Manager
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Integrated CMC Strategy: Designed RA-QA-TechOps collaborative framework for gastro-intestinal product lifecycle management
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Quality Excellence: Partnered with QA to establish proactive compliance monitoring, achieving consistent first-time approval success
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Manufacturing Alignment: Worked directly with Tech Ops for process validation strategies and stability study designs
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Cost Optimization: Achieved early approvals through integrated RA-QA-TechOps planning and risk mitigation strategies
Education
2005- 2007
Faculty of Pharmacy
Université Louis Pasteur Strasbourg
Master Pharmaceutical Engineering
2002-2005
Université Louis Pasteur Strasbourg
Bachelor in Chemistry and Biochemistry (Dual Qualification)
