Regulatory Submission Professional

Why Patients Need You

The ever-changing regulatory environment makes it necessary that Pfizer has knowledgeable and skilled Regulatory teams. This position is located in the nonclinical toxicology division (i.e. DSRD) of Pfizer; specifically, within the Global Portfolio & Regulatory Strategy group which is responsible for providing nonclinical toxicology support for submissions to regulatory agencies worldwide. Our patients need dedicated colleagues like you who are experts in their field and can keep their well-being as their topmost priority.

What You Will Achieve

Reliable documentation support forms an essential component of our regulatory group. You will beresponsible for providing submission-ready support to multiple disciplines across DSRD to ensure all  regulatory submissions, submission supporting documents, and nonclinical study-related  documents conform to Pfizer-standards and regional (ICH) and country specific regulatory requirements. The range of document  types include, but are not limited to, CTAs, INDs, MAAs, NDA/BLAs,and responses to agency queries. Accountable for ensuring nonclinical components of regulatory submissions of all types, formats and complexities are generated consistent with business priorities and delivered on or ahead of schedule to our partners, assuring nonclinical are never the limiting factor preventing program milestones from being achieved.

You will ensure 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, General Toxicology) to drive continuous improvement in document management processes at all sites. As an associate, your focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues. You may be asked to 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. You may also help lead and coordinate nonclinical submission operational activities across nonclinical lines (DSRD, PDM, Nonclinical Pharmacology). It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

REGULATORY SUBMISSIONS

• Assigned to specific programs, you will partner and provide dedicated support to the program-assigned Regulatory Toxicologist (RT) and Regulatory Submission Scientist (RSS)
• Prioritizes and manages submission requests and workloads based on information provided from the DSRD Drug Safety Team Lead (DSTL), and Regulatory Toxicologist .
• Ensure 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’s bookmarks, and hyperlinks meet MS Word SRC Standards; redistilling of PDF’s received from third parties), and ensuring a single PDF renditions formatting and navigations meet Submission Ready Standards
• Serve as a Global Document Management System (GDMS) Document Coordinator and SME for DSRD, supporting the upload, routing, finalization and distribution of various internal and external documents (including SEND data files). Select appropriate object type, enter attributes, update formatting if necessary, generate PDF version with appropriate navigations, and issue document.
• Collaborate with DSRD Project Team Leaders, DSRD Regulatory Strategists, DSRD Submission Scientist colleagues, and WRS to share knowledge, align expectations and establish action plans to prepare submission documentation to agreed upon timelines..
• Ensure Pfizer Global Style Guide and RuleBook requirements are met.
• Supports colleagues on use of SR templates, acts as SME for SR formatting and supports all documentation needs during regulatory filings.
• Conduct QC review of documents included in, or in support of, regulatory submissions.
• Perform critical evaluation of CTD (esp. Module 2 and 4) submission structures for logic, suitability and compliance with regional requirements.
• Participates and manages projects to implement new versions and interim updates of the Pfizer Submission Ready Templates (PREDICT).
• Promote utilization, maintenance, and improvement of tools and document management systems used in regulatory submissions.
• Contribute to SOP content related to document management and submission readiness processes.
• Review performance standards and serve a critical role in technology, process improvement, and other operational initiatives that are related to or interface with the regulatory submission processes/systems.
• Develop to become a key SME representing RSPs for Submission-Ready (SR) initiatives, submission formatting requirements, and document management workflows.

STUDY SUPPORT

• Collaborate with DSRD colleagues to ensure that appropriate information is included in DSRD study reports and are in electronic submission ready format.
• Monitor the Submissions mailbox and RSP Work Requests, directing requests to specific program-assigned RSPs.

DOCUMENT MANAGEMENT

• Lead efforts to ensure creation and maintenance of regulatory acceptable templates for regulatory submission and study related components
• Support e-archivist activities by ensuring accurate archiving of Pfizer electronic documents. Educate colleagues on archiving requirements and processes. Streamline processes for data retrieval of legacy dossiers.

ADDITIONAL DUTIES

• Promote quality as a best practice within DSRD based on knowledge of regulatory requirements, departmental guidelines, and QC experience.
• Support Acquisition, Collaboration and Divestiture activities, document and data transfers and interface with Business Development and DSRD Licensing Group.
• Foster training and development of colleagues in the application of technologies and tools to support study and regulatory submission document publishing.

Qualifications

Must-Have

• Bachelor’s Degree or 1 year of experience in a similar role (document specialist within the pharmaceutical industry preparing dossiers to regulatory standards).
• Experience preparing regulatory documents required, with knowledge of regulatory submission document principles and requirements are desired.
• Experience managing a complex workload with often conflicting timelines in a matrix environment.
• Familiarity with scientific terminology and knowledge of the drug development process.
• Proficiency in written and spoken English.
• Experienced and proficient with computer and software applications, previous experience with document management, training, and archival systems such as Adobe Acrobat, Microsoft Office Suite, Sharepoint.
• Robust knowledge of electronic repositories and document management systems.
• Ability to work independently as well as part of a team.
• Excellent interpersonal, communication and negotiation skills.
• Proactive, able to anticipate needs and respond in a timely fashion when required by the business.

Nice-to-Have

• Bachelor’s or Associate's Degree in a scientific or administrative services field.
• Familiarity with SEND and/or SEND requirements
• Project Management and Change Management skills.

Other Job Details

• Last Date to Apply: December 22nd, 2021

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

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.

Regulatory Affairs

#LI-PFE