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|Regulatory Toxicologist, Nonclinical Regulatory Strategy Lead, A.R. Fellow|
Location: Pearl River, NY
Employment Type: Full Time
Date Posted: 06/12/2021
Expire Date: 08/09/2021
Job Categories: Biotechnology and Pharmaceutical, Government and Policy, Healthcare, Practitioner and Technician, Legal, Quality Control, Research & Development, Medical, Writing/Authoring
Regulatory Toxicologist, Nonclinical Regulatory Strategy Lead, A.R. Fellow|
This position is in Regulatory and Immunosafety Science (RIS) line of Drug Safety Research and Development (DSRD), the nonclinical toxicology group within Pfizer Worldwide Research Development & Medical (WRDM). Regulatory toxicologists (Regulatory Strategy Leads [RSL]) are the nonclinical regulatory experts, providing nonclinical regulatory strategy leadership and advice on matrixed project teams. This RSL will have broad drug development experience (including national and global nonclinical regulatory guidelines) and will be the lead author on all nonclinical regulatory submission documents (worldwide pre-FIH through the life cycle of the asset) working in close partnership with the Drug Safety Team Lead (DSTL). In addition, the RSL may represent DSRD at WRDM level safety councils and governance teams as well as represent Pfizer at external industry consortium leading the conversation on advancing the science in the regulatory space. As an experienced toxicologist, the individual may also serve as a DSTL on mRNA specific project teams to provide toxicology testing strategy and issue management support from idea to loss of exclusivity. Individuals may be assigned to due diligence teams to assess potential acquisition or licensing candidates and work with internal experts to manage safety aspects of product quality issues. The candidate will support mRNA platform programs within all therapeutic areas.
+ Provide nonclinical toxicology regulatory science advice and consult to DSRD team lead and DSRD Therapeutic area leads.
+ Lead author of all nonclinical toxicology components of any submission to global health authorities.
+ Coach/mentor more junior colleagues to support this role in future submissions.
+ Lead or be active member of Pfizer WRDM or DSRD teams optimizing submission requirements/processes.
+ Lead external industry consortium/scientific efforts to optimize submission requirements and processes for mRNA technology.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
+ PhD in toxicology or related science or DVM.
+ Drug development experience/expertise
+ Minimum 5 years drug development experience as part of a drug development project team including nonclinical toxicology regulatory submission authorship
+ MS in Toxicology with a minimum of 8 years pharmaceutical drug development experience as part of a project team including regulatory writing experience
+ Strong scientific knowledge in toxicology and risk management.
+ Excellent English writing and verbal skills.
+ Able to handle multiple projects from many therapeutic areas as part of workload.
**Other Job Details:**
Last Date to Apply for Job: July 12th, 2021
Additional Location Information: Pearl River, NY; Cambridge, MA
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**EEO & Employment Eligibility**
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
Research and Development