Remote - Senior Regulatory Toxicologist
Company: Shepherd Regulatory Search
Posted on: June 25, 2022
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
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
- 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
- Review, analyze, and interpret scientific data, and effectively
communicate data interpretation to project teams, clients, and
- Author and/or critically review nonclinical submission packages
for scientific content and quality.
- Act as nonclinical representative for Agency interactions and
- Conduct scientific assessments (e.g., gap analysis, safety
- MS or Ph.D in toxicology or a related and relevant scientific
- 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
- Track record of successfully authoring quality nonclinical
- Knowledgeable in regulatory guidance documents, precedents, and
- 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
- Must have a client service-minded attitude and be able to
Keywords: Shepherd Regulatory Search, Raleigh , Remote - Senior Regulatory Toxicologist, Other , Raleigh, North Carolina
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