Sandrine Segura

Sandrine Segura

Director, CMC, Drugs and Biologics

Key Knowledge Areas:

- Pharmaceutical development activities
- CMC regulatory affairs
- Project Management

Pitch

Sandrine has a broad experience in pharmaceutical development, overall drugs / cosmetics development, CMC regulatory affairs and project management gained through more than 20 years of experience working within pharmaceutical industry.

 

About Sandrine

Sandrine has been involved in various international development projects.

 

  • Pharmaceutical development activities : management of operational and strategic activities for the development of products ; coordination of all CMC activities in formulation, analytical development, process scale-up, pre-clinical and clinical supplies (Ph I – II- III), and transfer to CMO.
  • CMC regulatory activities : definition and implementation of CMC regulatory strategy for development projects, scientific advices with Health Authorities, CMC regulatory documents (IND, IMPD, IDE, CTD module 3, NDA, BLA, PMA etc), life cycle management.
  • Project management : coordination of CMC activities, leading cross functional meetings, acting as project manager and/or alliance manager with subcontractors and partners; due diligence, gap analysis, expert reviews.

Background/Past experience

Sandrine is a formulation chemistry engineer, with a Master’s degree in Galenics, a Master’s degree in Project Management and a Certificate of Pharmaceutical Management. In 2018 she obtained the Project Management Professional certificate (PMP from PMI®).

 

Sandrine started her career as formulation development manager.  She gained hands-on experience in formulation development, process scale up and patents. She is designated inventor in numerous formulation patents. She then moved to a new position as CMC project manager, coordinating pharmaceutical activities on international development projects (NCE- topical, oral, parenteral routes-, biologics, cosmetics, dermal fillers) from selection of API to phase III programs and registration with a broad geographic coverage (incl. US, EU, Canada, Japan). As CMC expert she gained hands on experience during the last 12 years in CMC regulatory strategy, scientific advice meetings (FDA/ EMA / national agencies), elaboration of CMC regulatory documents and answer to questions from Health Authorities. She was Module 3 leader for two blockbusters in the past 6 years, registered in more than 65 countries.

 

After 21 years of experience in the pharmaceutical industry, Sandrine moved to consultancy and joined Blue Reg in May 2018.

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