Division: Regulatory Affairs
Company: Vifor Pharma
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 both developmental and lifecycle opportunities related to the Vifor portfolio
• Ensure and lead proper FDA interactions on key projects
• Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
• Interface with global RA colleagues and to provide input regarding FDA processes and ensure the implementation of FDA NDA holder requirements within the organization.
• Develop and/or review regulatory documents to ensure that all submissions are of high quality
• Work with US RA colleagues to support peaks in advertising & promotion review workload (coordinating with the RA Promotional Review lead as needed)
• 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 6 years in pharmaceutical or biotech industry in regulatory affairs
- Understanding of FDA regulation and 21 CFR sections related to drugs and biologics; solid understanding of where to seek and how to interpret regulatory information.
- Familiarity with 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
At Vifor Pharma, we use our skills, dedication, and entrepreneurial spirit to offer innovative solutions in iron deficiency, nephrology and cardio-renal therapies, so we can help patients around the world live better, healthier lives. This is why we come to work every day.
Are you empowered to create a better world, and be part of life changing work? As a global pharmaceutical company, we offer the chance to be part of a worldwide team, where passion and commitment are met with opportunities for professional and personal development. Learn more at viforpharma.com/career.
As we work to support patients, we also take care for our employees’ professional and personal growth and well-being. We show appreciation and recognition through attractive benefits that will enhance your life, develop you, empower you to grow, and create your own career journey with us.
If you find that the role above is not suitable for your experience or career goals, but you want to keep in touch and learn more about Vifor Pharma and future career opportunities, join our Vifor Pharma Talent Community.