Job Description

Why Patients Need You

The ever-changing regulatory environment makes it necessary that Pfizer has a knowledgeable and skilled Regulatory Affairs team. You will be part of a dynamic team that reviews and interprets the increasing regulatory requirements and their associated commercial pressures to facilitate the best patient care. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.

ROLE SUMMARY

The position is located in the nonclinical toxicology division (ie, 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\xe2\x80\x99s portfolio.

Candidate is responsible for electronic publishing and production of regulatory submissions that conform to regional (ICH) and country specific regulatory requirements. The range of submission types include, but are not limited to, CTA, IND, MAA Variation, NDA/BLA (low-to-high complexity), labeling submissions, periodic reports including marketing renewals, and responses to agency queries. Accountable for ensuring that regulatory submissions of all types, formats and complexities are generated consistent with business priorities and regulatory requirements.

Ensures that DSRD documentation is compliant with regulatory requirements/guidelines and meets Pfizer Global Style Guidelines using appropriate document management tools. Liaise with global DSRD colleagues and partner lines (Pharmacology, Regulatory, PDM) to drive continuous improvement in document management processes at all sites.

ROLE RESPONSIBILITIES

Performs all regulatory responsibilities in compliance with applicable regulatory standards.

REGULATORY SUBMISSIONS

• Compliant with and has working knowledge of Submission-Ready (SR) initiatives, submission formatting requirements, and document management workflows.
• Supports colleagues on use of SR templates and formats and supports all documentation needs during regulatory filings.
• Ensures document formatting is aligned with regulatory submission standards. Responsible for ensuring single native document formatting meets Submission Ready Standards (e.g., ensuring fonts, tables, auto field\xe2\x80\x99s bookmarks, and hyperlinks meet MS Word SRC Standards; redistilling of PDF\xe2\x80\x99s received from third parties), and responsible for ensuring a single PDF renditions formatting and navigations meet Submission Ready Standards.
• Enters various documents into document management system (including SEND data files). Applies metadata, updates formatting, if necessary, generates PDF versions with appropriate TOCs and hyperlinking, and issues document.
• Ensures Pfizer Global Style Guide and Rule Book requirements are met.
• Performs literature searches. Prepares DSRD contributions to periodic regulatory reports (eg, IND/NDA Annual Reports, PSURs, ASRs).

STUDY SUPPORT

• Collaborates with DSRD colleagues to ensure DSRD study reports are in electronic submission-ready format.

DOCUMENT MANAGEMENT

• Collaborates in efforts to ensure creation and maintenance of regulatory acceptable templates for regulatory submission and study related components.
• Assists with data retrieval of legacy dossiers and is able to search Document Long Term Storage.

ADDITIONAL DUTIES

• Promotes quality as a best practice within DSRD based on knowledge of regulatory requirements, departmental guidelines, and QC experience.
• Supports Acquisition, Collaboration, and Divestiture activities, document and data transfers, and interface with Business Development and DSRD Licensing Group.

QUALIFICATIONS

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.

• Bachelor\xe2\x80\x99s degree in a relevant life science subject or other equivalent qualification or applicable experience.
• Project Management skills desirable
• Experience with document management and archival systems such as, Adobe Acrobat, Microsoft Office, SharePoint is required
• Experience preparing regulatory documents, and regulatory submission document principles and requirements are desired
• Familiarity with scientific terminology and the drug development process
• Experience managing a complex workload and conflicting timelines in a matrix environment.
• Ability to work independently as well as part of a team
• Proficiency in English (verbal and written)
• Proficiency with computer and software applications

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.

Regulatory Affairs

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Pfizer