Job Description

Job Summary:

Functions as team member for the Tenders and ancillary support team, supports Global Tenders for Brands-Global Tenders team for all the human health products (small molecule and Bios) in all markets including tender bids from government agencies, hospitals, philanthropic organizations, etc. Responsible for managing, requesting, end to end tracking of CMC ancillary documents in ARS system requested by GCMC strategist for CMC submissions.

Tenders Support Responsibilities:

• Monitors GCTS tender mailbox and Outlook for requests.
• Searches Regulatory databases and collects and compiles CMC information requested for a tender before sending for review to the CMC GRL.
• Requests data from the sites as needed for a tender.
• Communicates with markets if clarification/prioritization is needed or extension of timeline is needed.
• Follows up with all responsible disciplines to be able to meet timelines.
• Works with CMC GRLs in finalizing the request and compiles final tender bid package for dispatch to the requestor.
• Maintains a record of information provided.
• Manages requests via the Submission Planning Application (Trackwise system).
• Supports use of regulatory systems and managing documentation and information, including setting up standard formats or reports for recurring requests and status updates as needed.

Ancillary Team Responsibilities:

Responsible for end-to-end tracking of CMC ancillary documents requested by GCMC strategists for CMC submissions.

The primary responsibilities are as follows:

• Routinely checks for new/updated ancillary document requests.
• Obtains clarification from the requestor, as needed.
• Determines if required ancillary document is available and current.
• Requests ancillary documents from appropriate sources, providing due dates and other appropriate information.
• Collaborates with site CNMs/COQAs.
• Notifies Team Lead and Requestor if due date concerns arise.
• Regularly follows up with the appropriate stakeholders to provide the document within the due date.
• Notifies the stakeholders of any update or rework in the existing ancillary request.
• Confirms appropriateness of the documents received.
• Coordinates with stakeholders to correct any errors found.
• Loads documents into GDMS, links documents/vDocs, as appropriate.
• Updates ancillary document requests in appropriate system, as needed.

Preferred Qualification:

• Minimum - Postgraduate in Pharmacy or Science
• Minimum 8 years of CMC experience within a regulatory function. Knowledge of tender driven market regulations is required and knowledge of EU/US and international regulatory practices, policies is preferable but not mandatory.
• Proficiency in Microsoft windows, Trackwise, Navigation or similar submission management tools, document management systems, publishing tools and operating knowledge of databases.
• Good verbal and written communication skills.
• Motivated, good interpersonal skills, organized, hardworking, agile, adaptable to change and able to meet timelines.
• Team player and ability to work in a highly matrixed environment.
• Customer focus and attention to detail and accuracy is required.
• Must be able to prioritize with some guidance. Ability to handle multiple projects with good prioritization skills. Willingness to work flexible hours.

Work Location Assignment: Flexible

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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