The position is located in the nonclinical toxicology division (i.e. DSRD) of Pfizer; specifically, within the Portfolio and Regulatory Strategy (PRS) group which is responsible for developing and implementing nonclinical toxicology and regulatory strategy for Pfizer's portfolio.
The Regulatory Submissions Scientist will support global regulatory dossier and query response preparation activities in collaboration with the Regulatory Toxicology Leads (RTLs) and Regulatory Submission professional (RSP), including populating templates with initial draft text and/or editing draft text, and conducting QC review of final draft text.
Specifically, she/he will help author Nonclinical Overviews, Written and Tabulated Toxicology Summaries (CTD Section 2.6.), Investigator Brochures (IBs), Briefing Documents, nonstandard data documents, including Powerpoint slides for regulatory meetings, and other nonclinical toxicology documents in support of drug development. She/he will prepare IND and NDA annual reports and updates of toxicology information in PSURs and other periodic reports, and will conduct QC review of regulatory submissions and associated documents, as appropriate, to ensure content reflects study data and conclusions in study reports, and assures compliance with international format expectations.
She/he will also lead and coordinate nonclinical submission operational activities across nonclinical lines (DSRD, PDM, Nonclinical Pharmacology).ROLE RESPONSIBILITIES
- Performs all regulatory responsibilities in compliance with applicable regulatory standards.
- Provides support for regulatory meetings and submissions:
- Collaborates with RTL to draft and finalize the 2.4 Nonclinical Overview (provides initial draft, incorporates edits from reviews)
- Generates the Toxicology Written Summary (Section 2.6.6)
- Prepares non-automated CTD tables and compiles Section 2.6.7. Toxicology Tabular Summary
- Oversees compilation and completeness of Module 4. Nonclinical Study Reports
- Assists other nonclinical lines (PDM, Pharmacology) in preparation/compilation of dossier sections as needed
- Assists in preparing pre-filing and advisory committee briefing documents
- Assists with IB preparation and collaborates with RSL to draft and finalize IB updates
- Reviews and summarizes relevant published literature
- Conducts QC review of submission-level documents to ensure content reflects study reports and conclusions
- Has a thorough understanding of study report and protocol GLP and OECD requirements and actively promotes best practices based on knowledge of those requirements.
- Supports RTL in preparation and review of responses to queries from regulatory agencies worldwide.
- Prepares DSRD contributions to periodic regulatory reports (eg, IND/NDA Annual Reports, PSURs, ASRs).
- Understands principles of risk assessment and supports preparation of toxicology assessments for impurities, formulation components, cleaning validation, and manufacturing support.
- Has working knowledge of international regulatory guidelines and standards and applies that knowledge to standardize templates and data presentations in accordance with global regulatory expectations.
- Leads and coordinates nonclinical submission operational activities across nonclinical lines (DSRD, PDM, Nonclinical Pharmacology).
The candidate should have a working knowledge of international regulatory guidelines and standards, and be able to apply that knowledge to standardize templates and data presentations in accordance with global regulatory expectations.
He/she should have a basic-advanced knowledge of toxicology and/or regulatory submissions, and/or one or more disciplines in the life sciences as relates to drug development, knowledge of international regulatory standards and expectations to establish and promote best practices in study and regulatory submission documents.BASIC QUALIFICATIONS
- Bachelor degree in a relevant life science subject, or other equivalent qualification.
- 10+ years experience in some relevant technical aspects of the toxicology of drug development and demonstrated skill in risk assessment technical writing and/or advanced QC review is required.
- Working knowledge of Microsoft Office applications is required, along with good organizational skills and attention to detail, and ability to handle multiple complex projects at the same time.
Pfizer 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 Act
- Knowledge of nonclinical regulatory submission dossiers, and/or study report preparation of toxicology study reports or risk assessments. Demonstrated skill in strategic thinking, and/or project management.
Pfizer 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 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