Pfizer Regulatory Submission Scientist Job For BSc Life Sciences, Apply Online. Pfizer is hiring candidates for a Regulatory Submission Scientist vacancy. Interested and eligible applicants can check out all of the details on the same below –
Hey there, looking for some insight into what types of interview questions can be asked for a Regulatory Submission Scientist role at Pfizer? Then check them out below
Job Title – Regulatory Submission Scientist
Job ID – 4881247
Location of Pfizer Vacancy –
- India – Chennai
- APAC – Any Pfizer Site
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
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Research and Development
Hey there, looking for some insight into what types of interview questions can be asked for a Regulatory Submission Scientist role at Pfizer? Then check them out below
- Can you explain your experience in regulatory submissions and its importance in the drug development process? Answer: Regulatory submissions are critical in ensuring compliance with regulatory standards and obtaining approval for new drugs. I have been involved in preparing and reviewing nonclinical toxicology documents, such as nonclinical overviews, toxicology summaries, and briefing documents, as well as submitting IND and NDA annual reports. I understand the importance of accurately reflecting study data and conclusions and complying with international format expectations.
- How do you ensure compliance with regulatory standards and guidelines while preparing regulatory submissions? Answer: To ensure compliance, I have a thorough understanding of study report and protocol GLP and OECD requirements. I actively promote best practices based on these requirements and stay updated on international regulatory guidelines and standards. I also collaborate closely with regulatory teams, subject matter experts, and drug safety team leads to review and incorporate their inputs in the submissions.
- Can you describe your experience in conducting quality control (QC) review of regulatory submissions? What aspects do you focus on during the review process? Answer: As part of my role, I have conducted QC reviews of submission-level documents to ensure content accuracy and adherence to study reports and conclusions. During the review process, I focus on verifying that the data presented in the submissions align with the study reports, ensuring compliance with regulatory guidelines, and maintaining consistency in data presentation and formatting.
- How do you handle multiple complex projects simultaneously while maintaining attention to detail and meeting deadlines? Answer: I prioritize tasks based on their urgency and impact on project timelines. I am adept at managing my time efficiently and utilizing organizational skills to keep track of multiple projects. Attention to detail is crucial, and I ensure thoroughness in my work by double-checking information, conducting meticulous reviews, and seeking feedback from team members when necessary.
- Can you provide an example of a challenging situation you faced during the preparation of a regulatory submission? How did you handle it? Answer: In one instance, while preparing a regulatory submission, there was a discrepancy between the study data and the conclusions mentioned in the study report. To address this issue, I collaborated with the relevant stakeholders, including the drug safety team lead and subject matter experts, to thoroughly review the data and reconcile the discrepancies. We amended the submission to accurately reflect the study findings and ensured compliance with regulatory requirements.
Note: These interview questions are hypothetical and based on the job description provided. Actual interview questions may vary depending on the interviewer and the specific requirements of the position.
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