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Remote - Senior Regulatory Toxicologist

Company: Shepherd Regulatory Search
Location: Raleigh
Posted on: June 25, 2022

Job Description:

Remote Position
We have a newly created full-time permanent opportunity for a Senior Regulatory Toxicology Consultant. In this role, you will work within the Nonclinical Safety & Development group and provide support to project teams and clients to develop and execute strategic and integrated nonclinical development programs for drugs, biologics, devices, and combination products in multiple therapeutic areas.
Organization: My client is a scientific consulting firm providing technical, regulatory, and product development services to developers, manufacturers, and marketers of pharmaceuticals and medical devices, and they are looking to expand their consultant team with an experienced scientific professional with strong interpersonal skills.
Responsibilities:

  • Devise and execute integrated nonclinical development strategies to support the development activities of drugs, biologics, devices, and combination products.
  • Advise, guide, and design integrated national and international nonclinical drug development strategies for our clients.
  • Provide oversight and management of program outsourcing activities.
  • Review, analyze, and interpret scientific data, and effectively communicate data interpretation to project teams, clients, and regulatory agencies.
  • Author and/or critically review nonclinical submission packages for scientific content and quality.
  • Act as nonclinical representative for Agency interactions and meetings.
  • Conduct scientific assessments (e.g., gap analysis, safety assessments).
    Requirements:
    • MS or Ph.D in toxicology or a related and relevant scientific field.
    • 8 or more years' experience working in nonclinical development, toxicology, and/or veterinary medicine in the pharmaceutical, biotechnology, and/or contract service industries.
    • Prior experience and knowledge in working with Contract Research Organizations (CRO).
    • Must possess current knowledge and expertise in regulated drug development processes.
    • Track record of successfully authoring quality nonclinical regulatory documents.
    • Knowledgeable in regulatory guidance documents, precedents, and GLP regulations.
    • Excellent communication skills and ability to effectively address scientific and regulatory questions under pressure.
    • Strong sense of teamwork and demonstrated experience working with project teams, clients, and regulatory personnel.
    • Must be detail-oriented, with an ability to think critically and innovatively.
    • Must have a client service-minded attitude and be able to travel.

Keywords: Shepherd Regulatory Search, Raleigh , Remote - Senior Regulatory Toxicologist, Other , Raleigh, North Carolina

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