Join Pfizer In Our Mission To Bring Life-Saving Medicines To Patients Worldwide Faster Than Ever Before. We're Committed To Maintaining The Highest Standards Of Excellence And Integrity In Everything We Do. As A Regulatory Affairs Associate, You'll Play A Crucial Role In Ensuring Pfizer's Medicines And Vaccines Reach Patients Efficiently And Safely.
- Position: Regulatory Affairs Associate
- Department: Regulatory Affairs
- Education: Bachelor's Degree
- Job Location: Flexible
Why Patients Need You:
Your Dedication And Expertise Will Help Expedite The Approval Of Pfizer’s Products, Expanding Global Access To Life-Changing Treatments. You’ll Navigate The Complex Regulatory Landscape, Representing Pfizer In Interactions With Regulatory Agencies And Negotiating To Accelerate Approvals.
What You Will Achieve:
- Serve As A Key Liaison Between Pfizer And Regulatory Authorities, Providing Strategic Direction To Project Teams.
- Ensure Compliance With Global Regulatory Standards And Streamline Submission Processes For Product Registrations.
- Contribute To The Development Of Regulatory Strategies And Support Teams Throughout The Product Lifecycle.
- Facilitate Approvals For Promotional Materials In Compliance With Regulatory Requirements.
- Identify And Mitigate Regulatory Risks Associated With Projects, Fostering Timely Communication And Resolution.
- Collaborate With Stakeholders To Define Filing Strategies And Meet Regulatory Requirements.
How You Will Achieve It:
- Meet Project Milestones And Deadlines While Adhering To Submission Standards And Procedures.
- Prepare Regulatory Documents And Provide Support For Technical Reviews And Strategic Discussions.
- Monitor Regulatory Developments And Competitor Intelligence To Inform Pfizer’s Strategies.
- Maintain Regulatory Databases And Ensure Compliance With Regulations.
Qualifications:
- Must-Have: Bachelor’s Degree
- Experience Managing Complex Regulatory Or Drug Development Issues
- Knowledge Of Regulations And Guidelines In Various Markets
- Strong Communication, Collaboration, Negotiation, And Problem-Solving Skills
- Proficiency In English, Both Written And Spoken
- Computer Literacy And Ability To Learn New Systems
Nice-To-Have:
- Knowledge Of Regulatory Processes And Therapeutic Areas
- Strategic Thinking And Project Management Skills
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