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A Range of Possibilities

Chemistry Manufacturing and Control Drug Substance regulatory affairs expert - All Gender

date posted 11/24/2022
contract type Full time
job id R2662279
location Sisteron, France

Les sites de Sisteron et Mourenx sont étroitement liés dans la fabrication de principes actifs par synthèse chimique.

La particularité du site de Sisteron ? Il abrite un centre de développement - fiabilisation des procédés, qui intervient en amont de toutdéploiement en production à l’échelle industrielle. 

Engagé dans la performance énergétique et la protection de l’environnement, le site a investi 12 millions d’euros pour réduire saconsommation électrique.

Le contenu du poste est libellé en anglais car il nécessite de nombreuses interactions avec nos filiales à l’international, l'anglais étant la langue de travail.

ABOUT THE JOB

Join Sanofi as CMC drug substance (DS) regulatory dossier expert/writer in R&D Synthetics department in a team including 2 other regulatory dossier expert/writers.

You and your team will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls (CMC) for development of innovative small-molecules drugs. In this role, you will have the opportunity to work on diverse cutting-edge projects, provide input into the product strategy, collaborate with global development teams and local sites as well as assuring regulatory submissions are on time and high quality.

About Sanofi

Sanofi Synthetics is the research and development unit of Sanofi, focused on innovative small molecules treatments on rare diseases, multiple sclerosis, and oncology. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.

Our ambition is to be the industry leader in innovative medicine. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi Synthetics laboratories.

Main responsibilities

In this role you will

  • Act as a CMC-Drug Substance Synthetics regulatory representative in the Drug Substance development project team
    • Represent the regulatory expertise in specific meetings, to facilitate product development
    • Propose regulatory strategy for small molecule development, such as the choice of the starting materials, a critical milestone for the CMC development of a drug substance
    • Provide accurate regulatory assessment and expert recommendation to the teams
  • Write CMC-DS sections of regulatory dossiers in a timely manner and with high quality
    • DS section of IND, IMPD, CTA, amendments, responses to questions from Health Authorities (HAs)
    • CMC part of Briefing books consultation such as type C meeting with FDA or Scientific advice with EMA on starting material choice, New Active substance status (NAS)
    • Collect and synthesize CMC source documentation (CMC development reports, etc.), regulatory requirements relevant for the product (ICH M7, nitrosamine assessment, stability, etc.)
    • As a member of the CTD submission task force
      • Write DS CTD sections (Module 3), module 2.3 of NDA, MAA
      • Complete reviews and review comments resolution at key review milestones of the CTD preparation (team review, management review, peer review, consensus meeting)
      • Be aware of regional specificities of CTD for Japan, China, Brazil for instance
      • Prepare responses to HAs’ questions during MAA or NDA reviews
      • Ensure high quality of CMC DS module content to ensure timely approval
  • Maintain a high degree of regulatory expertise
    • Keep up to date with the regulation (e.g., ICH, EMA, FDA, etc.)
    • Provide interpretive analyses of regulatory guidance, regulation or directives that impact CMC operations
  • Support compliance requirements and activities
    • Provide CMC regulatory assessment to change control management process
    • Support dossier compliance activities, HAs inspections and internal/international audits as needed
    • Support to post-approval variations preparation and writing in close relation with industrial site Regulatory Site Officer

ABOUT YOU

Experience

  • 3-5Y as regulatory CMC dossier writer with a Chemist or Analyst background
  • Background in small molecule development or life cycle management
  • Proven expertise/experience with assessing CMC source documentation/writing/reviewing CMC dossier documents
  • Experience in regulated pharma environment (research, development, manufacture or analytics)
  • Experience in complex supply chain project (multi-site manufacture or development projects, CDMO/CMO sub-contracted activities, multi-cultural environment)
  • Previously worked with external collaboration partners and CDMO/CMO

Soft skills

  • Team-working skills, experience with working/coordination in a cross-functional environment in development or Life Cycle Management space
  • Ability to communicate efficiently with other functional departments in the business
  • Analytical mindset with a problem-solving approach
  • Ability to work in multi-cultural and inclusive work-environment
  • Ability to multi-task and perform well under pressure in a constantly moving environment
  • End to end thinking, big picture in mind of what the end goals are for customers, Sanofi as a whole
  • Be result-driven for Patient with a quality-focused mindset and be able to drive a culture of continuous improvement in compliance with Sanofi’s behavioral and ethical standards

Technical skills

  • Knowledge of global regulations on small-molecule drugs
  • Ability to produce written and oral regulatory or scientific communications with clarity, accuracy and rigor
  • Excellent scientific writing skills in English
  • Proficient in using veeva vault RIM and other digital tools (MS word, Power point)

Education

  • University degree in a life-science discipline (Chemist, Analyst)

Languages

  • Good level in English/French (C1)

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

As part of its diversity commitment, Sanofi is welcoming and integrating people with disabilities.

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