Job Responsibilities:

• Functions as the Global Product Owner (GPO) or supports a GPO for Life Cycle Management (LCM), working with Cross-Functional Teams (CFT) to prepare regulatory submissions for US, Europe, Canada, Australia and ROW Countries.
• Responsible for the preparation and finalization of Global Regulatory Strategy Documents (GRSD), CTD sections of supplements / variations for LCM submissions and ensures effective data presentation and quality, by self or under guidance.
• Responsible for effective coordination with the cross functional teams, site and Global RA teams for the review and finalization of  supplements  to ensure effective data presentation and quality.
• 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 supports Change Control Assessment, by self or under guidance.
• Ensures commitments (module 2-5) made to health authorities are entered into tracking systems and are tracked to closure, as appropriate.
• Provide regulatory support for the assigned products, 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.
• Drives resolution of issues. Communicates issues, impact and outcomes to global regulatory management, Team lead and core team.
• Remains knowledgeable about current regulations and guidance, interprets and implements in the assigned projects.
• Responsible for ensuring compliance to Company’s submission standards, policies and procedures.

Qualifications

Must-Have

• Bachelor's Degree
• 3+ years of demonstrated experience in regulatory affairs or in a regulated industry
• Proven ability to manage complex regulatory issues and consistently deliver to time and quality standards
• In-depth knowledge of the current health regulatory framework for drug regulatory procedures
• Problem solving skills, strong detail, quality and compliance orientation
• Good verbal and written communication skills and fluent in English
• Proficient computer skills, e.g. MS Office, MS Outlook, Internet, database use

Nice-to-Have

• Master's degree
• Relevant pharmaceutical experience
• Strategic thinking with good project management skills

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