Regulatory Submission Scientist
About the job
Why Patients Need You
Pfizer’s purpose is to deliver breakthroughs that change patients’ lives. Research and Development is at the heart of fulfilling Pfizer’s purpose as we work to translate advanced science and technologies into the therapies and vaccines that matter most. Whether you are in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities to accelerate and bring the best-in-class medicines to patients around the world.
Role Summary
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 Drug Safety Team Lead (DSTL) 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.Candidate will also lead, coordinate, and/or assist in nonclinical submission operational activities across nonclinical lines (DSRD, PDM, Nonclinical Pharmacology).
Role Responsibilities
- Performs all regulatory responsibilities in compliance with applicable regulatory standards.
- Works under minimal supervision of a manager/senior scientist with high degree of independence.
- Document management support for submission-level documents and study reports includes
- Organizing and formatting submission-ready documents and files for regulatory submissions (Nonclinical Overview, Nonclinical Tabulated Summaries, Nonclinical Written Summaries, Study Reports)
- Working within Pfizer’s Global Document Management System (GDMS) to manage document preparation, review, and approval
- Requesting, compiling, and verifying published literature references
- Supports incorporation of CRO study reports into GDMS
- Conducts QC review of submission-level documents to ensure content reflects study reports and conclusions.
- Liaise with WSR and DSTL to prepare and review correspondence related to nonclinical queries and provide support for nonclinical sections in support of product license renewals.
- Leads and coordinates nonclinical submission process across nonclinical lines (DSRD, PDM, Nonclinical Pharmacology).
- 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 DSTL review and QC of responses to queries from regulatory agencies worldwide.
- Responsible for nonclinical sections of safety reports which include periodic review of sponsor-initiated studies and literature in the public domain for continuous analysis of relevant nonclinical safety information against current scientific knowledge.
- Raises attention to articles of interest to Subject Matter Experts, DSTLs, and/or PDM scientists for evaluation of importance or potential importance to the known safety profile of the product and is responsible to provide a response to WSR within the designated due date.
- Prepares DSRD contributions to periodic regulatory reports (eg, IND/NDA Annual Reports, PSURs, ASRs).
- 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.
- Candidate should have a basic to 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
- A minimal bachelor’s degree in pharmacy/Life Science and/or equivalent training/experience is required.
- 5+ years of experience in some relevant technical aspects of the toxicology of drug development and an intermediate or advanced level of knowledge in writing, analytical skills, and communication.
- 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.
- Ability to work independently as well as part of a team
- Proficiency in English (verbal and written)
Preferred Qualifications
- Knowledge of nonclinical regulatory submission dossiers, and/or study report preparation of toxicology study reports or risk assessments. Demonstrated abilities in influencing and negotiating and competency in managing work schedules and deadlines. Some experience in nonclinical toxicology aspects of drug development, or regulatory submissions is desirable.
- Excellent communication and presentation skills
Work Location Assignment: On Premise
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