Pfizer Regulatory Submission Operations Associate [6 in Suba, Colombia

Position Purpose:

Provide operational support to Hub Submission team within Submissions Management organization to prepare and deliver regulatory dossiers to regional or national countries for submission to the regulatory agencies.

Through application of standards and tools, execute designated operational tasks, including but not limited to dossier build, workflow management, translation coordination, quality control and archiving coordination, conforming to regulatory submission timelines and applicable regulatory obligations.

Primary Responsibilities:

  • Provide operational support to Hub Submission team execute designated tasks associated with submission coordination activities for assigned products and/or regulatory procedures as appropriate.

  • On behalf of Worldwide Safety & Regulatory (WSR), lead and manage logistical and technical aspects, ensuring development and delivery of X-regional, regional and/or national regulatory dossiers - initial application and subsequent lifecycle updates (compliance and maintenance).

  • Accountable for delivering quality and timeliness as per applicable policy, SOP/Work Instructions, guidelines or service level agreement.

  • Command necessary knowledge and skills of regulatory submission and ensure regulatory or business requirements are fulfilled.

  • Adhere to the appropriate use of technical tools, through use of working practices and QC/QA regimes, such that regulatory and internal compliance is preserved.

  • Escalate, inform, and/or resolve any issues that may impact timeline, quality or compliance of submissions.

  • Commit to completing required on-the-job training courses to ensure training compliance is preserved.

Technical Proficiency/Skill:

  • Breadth of knowledge and experience with the utilization of variety of software applications and/or tools. Technical proficiency is a key competency for this role

Qualifications (i.e., preferred education, experience, attributes):

  • B.S./B.Sc is in Life Sciences, Business or Information Technology (desirable).

  • Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.

  • Recent college graduate. Some part time previous job experience (desirable)

  • English (desirable)

  • Demonstrat ion of attention to detail .

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.