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Sanofi

Global pharma company; vaccines and R&D

Distinguished Scientist

Regulatory & Quality (Life Sciences)Posted on Nov 5
Full-time$178.5k - $257.8kIn-person

About the Job

Requirements

  • A PhD or DVM in biochemistry, toxicology, pharmacology, biology, physiology, or a closely related field, with 12 or more years of pharmaceutical industry experience in drug development and demonstrated experience in preclinical safety and toxicology.
  • Demonstrated knowledge and experience regarding Good Laboratory Practice and International Council for Harmonisation policies, and understanding of regulatory nonclinical testing requirements.
  • Demonstrated experience preparing and submitting Investigational New Drug and Common Technical Document submissions.
  • Ability to present preclinical safety data in a project team setting and/or health authority interactions.
  • Experience as a Good Laboratory Practice Study Director and/or Study Monitor.
  • Experience in conducting and interpreting ophthalmology toxicity studies and data.

Responsibilities

  • Serve as a Preclinical Safety Project Team Member on multifunctional Research and Development project teams covering small molecules, biotherapeutics, oligonucleotides, and other modalities.
  • Support development of new products and develop and implement toxicology and safety pharmacology strategies.
  • Support nonclinical safety activities for early- and late-stage development, life-cycle management, and marketed products.
  • Write nonclinical summaries for clinical Investigator Brochures, Investigational New Drug applications, Clinical Trial Applications, New Drug Applications/Biologics License Applications, Pediatric Investigation Plans, Scientific Advice, and other regulatory documents, or assist other Project Team Members with these activities as needed.
  • Review reports and other documentation authored by internal personnel, including Preclinical Safety and other Project Team functions, and/or external contract laboratories, to provide the appropriate preclinical safety scientific perspective.
  • Ensure high scientific standards in conducting and reporting nonclinical safety and investigative toxicology studies.
  • Provide scientific leadership within Preclinical Safety, particularly through experience conducting and interpreting reproductive and developmental toxicity studies and data.
  • Provide internal expertise for global nonclinical safety issues on expert groups or internal committees as required.
  • Prepare scientific publications and presentations from toxicology and safety pharmacology studies as appropriate.
  • Participate in special projects or inter-industry working groups as needed.
  • Provide scientific input on the design and analysis of Research and Development activities, including evaluations of external in-licensing opportunities, and ensure activities are completed to high scientific standards.
  • Oversee the nonclinical safety program for Research and Development drug candidates, including formulating nonclinical safety strategies, designing safety pharmacology and toxicology studies, authoring regulatory documents, participating in integrated Project Teams, interacting with internal and external partners, and responding to global regulatory agencies.
  • Review compounds for potential in-licensing opportunities and address nonclinical safety issues and risks for marketed products.

Desired Qualifications

  • Certification by the American Board of Toxicology.

About the Company

Sanofi

Global pharma company; vaccines and R&D

Sanofi is a global pharmaceutical and biotechnology company that develops, manufactures, and sells prescription medicines, over-the-counter products, and vaccines. Its products span immunology, oncology, rare diseases, and vaccines, addressing unmet medical needs through a strong focus on research and development. Sanofi's core product model relies on large-scale R&D, strategic partnerships, and licensing to bring new therapies to markets, with revenue generated from product sales and collaborations. The company differentiates itself by leveraging its global reach, diverse portfolio, and emphasis on patient-centric solutions, safety, and quality to navigate regulatory environments in developed and emerging markets. The company’s goal is to improve health outcomes and quality of life for people worldwide by delivering innovative treatments and vaccines that meet unmet medical needs.

Company size
10,001+
Company stage
IPO
Headquarters
Paris, France
Founded
1973

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