Pfizer Toxicology Regulatory Strategy Lead in Cambridge, Massachusetts
Our role can be based in Cambridge, MA or at our office in La Jolla, CA. Relocation benefits will be offered to qualified candidate.
The job is for a regulatory Toxicologist. They will be part of the Regulatory Strategy and Compliance (RSC) group within the toxicology (Drug Safety R&D) group in Worldwide R&D (WRD). This person reports into the global regulatory strategy lead in RSC. The primary function of the role is to be the nonclinical safety regulatory expert to project teams and serves as the lead author for nonclinical toxicology contributions to nonclinical submissions components within Pfizer. The role works with other professional within RSC to create and make submission ready e-CTD components of major submissions (eg., IND, NDA, BLA) as well as any other form of document used to communication to global health authorities (IB, PIP, DSURs, CAC, query responses and briefing documents).
The role works closely with toxicology project team leads (DSRD team lead [DSTL]) to provide full support to WRD project teams. The person may also serve as a DSTL on some projects carrying both roles (DSTL and RSL). The person also works with regulatory colleagues in other functional lines in WRD such as Pharmacology, Pharmacokinetics and drug metabolism, clinical, worldwide safety and regulatory to complete submissions.
The role supports the entire Pfizer WRD portfolio but expertise in biologics, gene therapy and vaccine drug development will be a key focus of this role to support those therapeutic areas and provide expert nonclinical toxicology regulatory counsel to DSRD and project team colleagues.
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 WRD or DSRD teams optimizing submission requirements/processes
Lead external industry consortium/scientific efforts to optimize submission requirements and processes
PhD in toxicology or related science or DVM
7 years drug development experience including nonclinical toxicology regulatory submission authorship
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
- Experience in development of biologics, vaccines or gene therapy products
Work involves sitting/standing at a desk using a computer
Some travel required
Ability to work effectively on teams
Abel to work in Word, Excel, PowerPoint
Able to effectively manage safety issues for benefit: risk assessments
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional business travel domestic and abroad
EEO & Employment Eligibility
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