Use Your Power for Purpose
Your dedication and expertise are crucial in bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is essential, especially in an ever-changing regulatory environment that demands forward thinking and meticulous attention to detail. By maintaining these high standards, you will help expand and accelerate patient access to Pfizer medicines and vaccines. Your role is vital in ensuring that we meet these challenges head-on, providing the necessary support to navigate complex regulations and ultimately deliver life-saving treatments to those in need.
What You Will Achieve
In this role, you will:
- Possess a thorough understanding and application of the Hub procedures.
- Understand local regulations and trends, as communicated by the CRS.
- Utilize a submission planning and forecasting tool to update timelines when necessary.
- Update the appropriate regulatory requirements systems and database promptly when market regulations change.
- Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values and which supports compliance, innovation and talent development and retention, as needed
- Complete departmental training in a timely manner to address corporate and regulatory compliance.
- Drive improved efficiencies across the region through achieving consistency in submission strategies and its execution. Make suggestions and recommendations that contribute to improvements in the Hub.
- Maintain an active partnership with counterparts across the Hub Regional team
Here Is What You Need (Minimum Requirements)
- Bachelor’s degree or equivalent
- Experience in regulatory affairs, preferably in human medicines
- Demonstrated experience and a proven ability to consistently deliver to time, cost, and quality standards
- Excellent organizational skills and attention to detail
- Knowledge of documentation practices
- Fluency in English, both verbal and written
Work Location Assignment: Hybrid
EEO (Equal Employment Opportunity) & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
Regulatory Affairs