Regulatory Affairs CMC, Associate Director

Ort: United States - Redwood City

Funktion: Regulatory Affairs

Firma: Relypsa

Senioritätslevel: Director

Ihr Profil

Responsibilities:

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.

Tasks:

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.

Qualifications:

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:
Minimum Requirements
- 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
Preferred Requirements
- MA/MS or PhD in life chemistry or chemical engineering, or PharmD preferred
- Experience in an international company with more than one marketed product

Über uns

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist. Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen. Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Die Vifor Pharma Gruppe besteht aus Vifor Pharma, Vifor Fresenius Medical Care Renal Pharma, ihrem gemeinsamen Unternehmen mit Fresenius Medical Care, Relypsa und OM Pharma.

Für mehr Informationen gehen Sie bitte auf: http://www.viforpharma.com/de/ueber-vifor-pharma/wer-wir-sind.

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