02 oct
|
Pfizer
|
Ciudad de México
02 oct
Pfizer
Ciudad de México
Use Your Power for Purpose
At Pfizer, we are committed to bringing medicines to the world with speed, without compromising on excellence and integrity. Navigating the ever-changing regulatory environment requires forward thinking and meticulous attention to detail. Adhering to both local and global regulations is crucial. Your dedication and expertise are vital in expanding and accelerating patient access to Pfizer's innovative medicines and vaccines. By maintaining our high standards and ethical practices, we ensure that patients receive the best possible care. Join us in our mission to make a meaningful impact on global health.
What You Will Achieve
As a Senior Associate in Regulatory Chemistry, Manufacturing, and Control Strategy at Pfizer, you will play a critical role in developing and implementing regulatory strategies for both small and large molecule pharmaceuticals. Your expertise will be essential in preparing regulatory submissions and liaising with health authorities to ensure compliance with global requirements.
- Contribute to project completion and manage time to meet targets.
- Support assembly of Chemistry, Manufacturing and Control (CMC) information for global regulatory submissions.
- Actively contribute to cross-functional initiatives to mitigate risks.
- Ensure compliance with submission standards, procedures, and policies.
- Prepare and finalize General Regulatory Strategy Documents and Clinical Data Request (CTD) sections for submissions.
- Maintain core dossiers and coordinate responses to deficiency letters.
- Review and apply regulatory guidelines for renewals.
- Recommend solutions and escalate issues with significant impact.
- Independently manage projects and execute strategies with minimal oversight.
- Collaborate with cross-functional teams to support regulatory strategies.
Here Is What You Need (Minimum Requirements)
- A BA /BS with 2+ years of experience, an MBA or MS with 0+ years of experience, an associate degree with 6+ years
📌 Regulatory Senior Associate Chemistry, Manufacturing, Controls (Ciudad de México)
🏢 Pfizer
📍 Ciudad de México