Location: United States - Redwood City
Division: Regulatory Affairs
Seniority Level: Director
• Provide strategic regulatory support to internal brand, product and project teams.
• Pro-actively monitors the latest regulations, guidance, and actions from the FDA and competitors that may influence the landscape and assesses the potential impact on the regulatory and/or business strategy and planning.
• Represent US regulatory and FDA perspectives within the Vifor global Regulatory Affairs teams. Work in close collaboration with Vifor global functions to integrate relevant aspects of US and global regulatory strategy.
• Support regulatory aspects of submissions and communications with FDA by global regulatory staff for Vifor products.
• Manage timelines and resources to achieve stated objectives, ensuring tracking tools and regulatory databases are maintained in an up-to-date manner.
• Provide strategic regulatory input on developmental and maintenance CMC projects
• Ensure and lead proper FDA interactions on key CMC projects.
• Oversee the preparation of CMC documents required by the FDA
• Communicate with global RA colleagues and ensure the implementation of FDA CMC requirements within the organization.
• Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on both development program and lifecycle opportunities
• Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
• Develop and/or review regulatory documents to ensure that all submissions are of high quality
• Interface with global Regulatory Affairs staff to provide input on US requirements or FDA processes
• Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages
• Develop and maintain current knowledge of US regulation and industry standards, and communicate requirements to others as needed.
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience, and knowledge, or the equivalent:
- BS, BA in a relevant discipline, or BSN
- Experience in regulatory xxx and in other areas of Regulatory Affairs
- At least 8 years in pharmaceutical or biotech industry in regulatory affairs
- Understanding of GMPs and GLPs; solid understanding of where to seek and how to interpret regulatory information.
- Strong and broad knowledge of CMC drug development
- Experience providing strategic CMC regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds
- Proficiency in Microsoft Word, Excel, PowerPoint, and Adobe Acrobat and PRC software
- MA/MS or PhD in life chemistry or chemical engineering, or PharmD preferred
- Experience in an international company with more than one marketed product