Why you should apply for a job to Pfizer:
4.1/5 in overall job satisfaction
4.5/5 in supportive management
78% say women are treated fairly and equally to men
79% would recommend this company to other women
81% say the CEO supports gender diversity
23-25 Week Maternity Leave (Fully paid for birth parents)
Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
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Position summary
- Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), working with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
- Responsible for the preparation of Global Regulatory Strategy Documents (GRSD) and CTD Sections of post approval submission.
- Provides guidance and support to Junior Product Owners in the preparation of GRSD and post approval submission.
- Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review.
- Responsible for effective review and providing timely feedback to the teams on technical documents including batch documents related to submission (Batch records, Exhibit batch and stability protocol).
- Provides regulatory assessment and support the Change Control Assessment with minimal guidance.
- To ensure commitments (module 2-5) made to Health Authorities are entered into tracking systems and are fulfilled to closure, as appropriate.
- Participates and provides inputs in technical reviews and Change Control reviews as assigned.
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- Remains updated about current regulations and guidance interprets and implements in the assigned projects.
Responsible for ensuring compliance to organization submission standards, policies and procedures.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
What are Pfizer perks and benefits
Paid paternity
Paid maternity
About the company
Pfizer is a leading research-based biopharmaceutical company. We apply science and our global resources to deliver innovative therapies that extend and significantly improve lives. We make medicines and vaccines that help people when they are sick and prevent them from getting sick in the first place. Every day, our colleagues work in developed and emerging markets to ...
Why you should apply for a job to Pfizer:
4.1/5 in overall job satisfaction
4.5/5 in supportive management
78% say women are treated fairly and equally to men
79% would recommend this company to other women
81% say the CEO supports gender diversity
23-25 Week Maternity Leave (Fully paid for birth parents)
Family building benefits include $35,000 fertility services + $25,000 adoption and surrogacy services
Pfizer is a founding member of Healthcare Businesswomen's Association Gender Parity Collaborative
