Sylvain Simon
Senior Manager Regulatory Affairs at CARBOGEN AMCIS | Basel, Basel, Switzerland
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Sylvain Simon currently serves as Senior Manager of Regulatory Affairs at CARBOGEN AMCIS, where he plays a pivotal role in shaping the company's regulatory and CMC strategies within the biotech and pharmaceutical sectors. Leveraging extensive hands-on experience in regulatory compliance and Chemistry, Manufacturing, and Controls (CMC), Sylvain specializes in API and Drug Substance manufacturing, ensuring that all processes adhere to stringent GMP standards and regulatory requirements. His expertise encompasses the development and control of biologics, ADCs, and bioconjugates, with a deep understanding of drug product technology and analytical chemistry techniques such as ELISA and LIMS systems.
In his current role, Sylvain is responsible for leading complex regulatory projects, including the preparation and maintenance of CTD Module 3 Quality dossiers for IND, IMPD, BLA, and MAA submissions. He provides strategic guidance on CMC development from early phase clinical trials through to post-approval lifecycle management, ensuring seamless technology transfer and compliance across global markets. Sylvain also contributes to the development of regulatory strategies at the corporate level, aligning CMC and regulatory objectives with business goals to facilitate timely market access for innovative biopharmaceuticals.
As Deputy Head of Regulatory Affairs, he collaborates closely with cross-functional teams to navigate the evolving landscape of biologics and ADC regulations, ensuring that CARBOGEN AMCIS remains at the forefront of industry standards. His skills in GMP, analytical chemistry, and biopharmaceutical development underpin his ability to deliver compliant, high-quality regulatory dossiers, supporting the company's mission to advance cutting-edge therapies in a highly regulated environment.
Senior Manager Regulatory Affairs at CARBOGEN AMCIS in April 2023 to Present
Manager Regulatory Affairs at CARBOGEN AMCIS in June 2018 to April 2023
Bioprocess Expert 2 Multiproducts Unit at Novartis in May 2013 to May 2018
Product Process Engineer - IPV vaccine at Sanofi Pasteur in November 2012 to April 2013
Analytical Laboratory Manager / Head AP&T at Sanofi Pasteur in April 2012 to October 2012
Product Process Engineer - Rabies vaccine at Sanofi Pasteur in November 2011 to April 2012
Trainee Biotechnology – Virology Engineer at Sanofi Pasteur in January 2011 to August 2011
Microbiology – Immunology Lab Manager at High School SAINT MARC in September 2006 to September 2010
Biochemistry Teacher at High School /University (Grenoble, France) in September 2001 to September 2006
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EICNAM, Biotechnology Engineer degree, August 2026
CNAM LYON, Advanced professional degree - Biological industrial Manager – Major in quality assurance management, August 2026
Ecole Normale Supérieure LYON, August 1998 to August 2026
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CMC
Validation
GMP
FDA
Biotechnologie
Biotechnology
Sop
Technology Transfer
Pharmaceutical Industry
HPLC
Chromatography
LIMS
Microbiology
CAPA
Analytical Chemistry
ELISA
SDS-PAGE
Lifesciences
Biophamarceutique
Culture de cellules
Biochimie
Contrôle des modifications
Affaires réglementaires
Immunologie
Système qualité
Assurance qualité
Biologie cellulaire
Management
Vaccins
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Discover more about CARBOGEN AMCISWhat is Sylvain Simon email address?
Email Sylvain Simon at [email protected] and [email protected]. This email is the most updated Sylvain Simon's email found in 2026.
What is Sylvain Simon phone number?
Sylvain Simon phone number is +33664940777.
How to contact Sylvain Simon?
To contact Sylvain Simon send an email to [email protected] or [email protected]. If you want to call Sylvain Simon try calling on +33664940777. (updated on April 10, 2025)
What company does Sylvain Simon work for?
Sylvain Simon works for CARBOGEN AMCIS
What is Sylvain Simon's role at CARBOGEN AMCIS?
Sylvain Simon is Senior Manager Regulatory Affairs
What industry does Sylvain Simon work in?
Sylvain Simon works in the Pharmaceuticals industry.
Sylvain Simon Email Addresses
Sylvain Simon Phone Numbers
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