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
#4869534
Position summary
- Functions as the Global Product Owner (GPO) or Support GPOs for Life Cycle Management (LCM), coordination with cross-functional teams to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
- Finalization of Global Regulatory Strategy Documents (GRSD) and CTD Impacted Sections of post approval submissions.
- Guidance and Support to Junior Product Owners in the preparation of GRSD and post approval submissions.
- Coordination with the cross functional teams (CFT), site and Global RA teams for the review and finalization of submission contents before it’s submission to the Heath Authorities.
- To ensure review of the technical documents and providing feedback to CFT during the change control assessment.
- To ensure the fulfillment of commitments (Module 2-5) made to the Health Authorities are entered into tracking systems and are fulfilled to closure, as appropriate.
- Identifies and assesses regulatory risks associated with assigned projects and timely communication to the team to quickly mitigate the risks.
- To discuss issues, impact and outcomes during assessment of changes with Team Lead and core team.
- Remains updated about current regulations and guidance, interpret and implement in the assigned projects prior concurrence from regulatory leads.
- Responsible for ensuring compliance to organization submission standards, policies and procedures.
- To coordinate with Drug Shortage Management Team for preparation, review and submission to USFDA.
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#LI-PFE
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
