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
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
