Job Summary
Regulatory Affairs Specialist is responsible for the implementation of clinical trial application and product life-cycle management in compliance with local regulations and Company Standard Operating Procedures (SOPs).
Job Responsibilities
Product life-cycle management & GMP maintenance
- Ensure the assigned products and GMPs are maintained in full compliance with local regulations and company SOPs with the guidance from line manager
- Ensure key changes of the assigned products are closely communicated with relevant internal stakeholders to ensure readiness of change implementation
Clinical Trial Application (CTA)
- In partnership with above-country operational hubs, above-country regulatory strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries
Relationship management with stakeholders
- Cooperate with relevant stakeholders to share information & provide a good understanding on RA-related issues.
- Attend Association Meetings and get most updated regulatory information.
Regulatory compliance
- Complete required trainings and comply with relevant standards to ensure compliance to Pfizer Policy and SOPs
Qualifications / Skills
- Professional expertise in pharmaceutical science
- Good communication skill
- Problem solving
- Analytical thinking
- Project management
- Teamwork
Qualifications
Training & Education Preferred:
Bachelor degree or above, major in pharmacy or other science-related background.
Prior Experience Preferred:
Some regulatory related experience
English Skill
TOEIC Score650
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Regulatory Affairs
