A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Toxicologist responsible for nonclinical regulatory strategy, and design and execution of nonclinical studies primarily in support of anti-infectives portfolio. Toxicologist will also be part of a global nonclinical team supporting generics, sterile injectables and biosimilars across multiple therapeutic areas.
* Regulatory strategy: Prepare and review correspondence with worldwide regulatory agencies. Respond to nonclinical queries from regulatory agencies. Serve as an expert nonclinical safety consultant regarding current international regulatory guidelines
* Portfolio: Focus area will be design and execution of nonclinical strategy for support of anti-infectives portfolio. In addition, the toxicologist will work collaboratively with a small nonclinical team to support a diverse portfolio that includes generics/sterile injectables (to support ANDA and 505b2 submissions) and biosimilars across multiple therapeutic areas
* Contribute expert nonclinical safety sections to regulatory dossiers and oversee the integration of all nonclinical contributions (pharmacology/ADME/toxicology) * Participate in due diligence efforts - identify potential gaps and/or opportunities in nonclinical components of business development activities
* Demonstrate subject matter expertise in at least one of the following areas: impurity, excipient, and leachable/extractable safety qualifications, developmental and reproductive toxicology, genetic toxicology
* Work with other subject matter experts across the broader R&D organization as needed to address nonclinical needs of the portfolio
* External influence efforts will focus on development and implementation of strategies to influence the regulatory environment in support of streamlining registration processes