Associate Research Fellow, Regulatory Toxicologist, Nonclinical Regulatory Toxicology Lead

Company: Pfizer
Location: Cambridge
Posted on: August 4, 2022

Job Description:

This position is in Drug Safety Research and Development (DSRD), the nonclinical toxicology group within Pfizer Worldwide R&D. Regulatory toxicologists (Regulatory Toxicology Leads [RTL]) are in the Portfolio and Regulatory Strategy (PRS) line within DSRD. The primary role of the RTL is to serve as the nonclinical regulatory expert on cross-line matrixed project teams and as lead author on all nonclinical regulatory submission documents (worldwide pre-FIH through LOE). This includes all toxicology-related regulatory documents or sections (ie INDs, NDAs, BLAs, IBs, PIPs, DSURs, CACs, briefing documents, queries, etc) and the responsibility to develop the scientific and strategic message for a high quality nonclinical package. Candidates will also help to ensure compliance of dossiers to global health authority standards and work closely with regulatory submission scientists and document specialists in the PRS line. Thus the candidate is expected to have a solid grasp of nonclinical regulatory guidelines and strong regulatory writing and verbal skills. The RTL also works closely with the Drug Safety Team Lead (DSTL) to provide full regulatory and strategic nonclinical support to project teams. In addition, the candidate will be involved in developing and implementing strategies to influence the internal and external (health authorities) nonclinical regulatory environment. Candidates will be involved in internal and external working groups and consortia including working with organizations such as PhRMA, DruSafe and/or BioSafe to influence the nonclinical regulatory environment. In addition to serving as the RTL on teams, individuals may also serve in a joint role as RTL/DSTL on project teams and provide scientific project strategy and issue management support from idea to registration as well as full regulatory strategy support. Individuals may be assigned to teams to assess potential acquisition or licensing candidates. The candidate will support all therapeutic areas and both small and large molecule modalities. For this position, the preferred candidate will have experience in the regulatory space for post marketed compounds (renewals, 505 (b)2, support for label and formulation changes, etc)Basic Qualifications:

• Advanced degree such as a PhD, MD, or DVM and expertise in Toxicology, Pathology or allied biological sciences
• Experience level should be a minimum of 7 years experience in Pharmaceutical development and competency in post marketed product maintenance as well as expanded indications and patient populations to extensive experience and skill in crafting expert nonclinical summary documents and working directly with regulatory agencies and industry consortia on the regulations governing nonclinical pharmaceutical development.
• Experience in nonclinical aspects of pharmaceutical drug development, early, late-stage and post market project strategy, and regulatory submissions and regulatory strategy.
• Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to author regulatory documents of high quality, appropriate decision making regarding candidate development and regulatory submissions, ability to communicate verbally and in written context well across business lines, and effective leadership of teams of diverse expertisePreferred Qualifications:
  • Specific working knowledge of nonclinical safety requirements in the post marketed space (supporting candidate maintenance such as renewal registrations, new indications, formulation changes, etc)PHYSICAL/MENTAL REQUIREMENTSAbility to formulate a concise summary of complex safety (toxicology, pharmacokinetics and biology) data from multiple sourcesNON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS NoneOther Job Details:
    • Last Date to Apply for Job: August 5, 2022
    • Additional Location Information: La Jolla, CA, Groton, CT and Pearl River, NY
    • Eligible for Relocation Package: YES
    • Eligible for Employee Referral Bonus: YESPfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer 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#LI-PFE

Keywords: Pfizer, Cambridge , Associate Research Fellow, Regulatory Toxicologist, Nonclinical Regulatory Toxicology Lead, Other , Cambridge, Massachusetts