Sylvain Simon Email & Phone Number

Sylvain Simon

Senior Manager Regulatory Affairs at CARBOGEN AMCIS | Basel, Basel, Switzerland

Sylvain Simon Socials
About Sylvain Simon

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.

Sylvain Simon Work
1 experience icon

Senior Manager Regulatory Affairs at CARBOGEN AMCIS in April 2023 to Present

2 experience icon

Manager Regulatory Affairs at CARBOGEN AMCIS in June 2018 to April 2023

3 experience icon

Bioprocess Expert 2 Multiproducts Unit at Novartis in May 2013 to May 2018

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Sylvain Simon Education

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

Sylvain Simon Skills

CMC

Validation

GMP

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About Sylvain Simon's Current Company
Frequently Asked Questions about Sylvain Simon

What 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

Email Sylvain Simon at [email protected] and [email protected]. This email is the most updated Sylvain Simon's email found in 2026.

Sylvain Simon Phone Numbers

Sylvain Simon phone number is +33664940777.
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