Vice President, Regulatory Affairs Strategy- Oncology & Hematology

The role leads a group within Regeneron’s Regulatory Affairs organization that provides guidance to Research, Regeneron Genetics Center, Regeneron Cellular Medicine, the Oncology and Hematology Clinical Development Units on regulatory strategies for the development of Oncology & Malignant Hematology drug products to ensure all corporate objectives are met within specified timelines and vital state of compliance is maintained. In addition, the position acts as a trusted advisor to senior management regarding Regulatory strategies / processes while developing organizational objectives and, importantly, understanding the impact of decisions across functional areas.

As a strategic leader within the Regulatory Affairs organization the incumbent will be instrumental in the evolution of Regeneron’s burgeoning Oncology & Hematology medicine development candidates by leveraging cross-functional relationships. In addition, the incumbent will lead strategic development of a highly functioning department to meet current and anticipated demands.

A typical day in this role might include...

• Drive decision making on regulatory strategies for development of Oncology & Malignant Hematology product candidates to ensure Regulatory Agency approval(s) within specified timelines of all activities in support of organizational development and marketing objectives.
• Designs regulatory communication strategy for Oncology & Malignant Hematology product candidates and ensures liaison alignment for projects as well as Agency interactions.
• Lead all aspects of the completeness and accuracy of information provided in regulatory submissions.
• Lead and advise the planning, preparation and submission of all regulatory documentation.
• Active member of Protocol Review Committee and Development Program Review Committee
• Leads and manages liaisons and / or provides direction to regulatory representatives and project teams who partner with multidisciplinary teams on the content, format, style architecture and timing of regulatory submissions.
• Evaluate applications and conformance with the regulatory requirements, clarity, and completeness.
• Serve as the regulatory expert in Oncology & Malignant Hematology and recommend innovative solutions to sophisticated Regulatory matters
• Maintain good relationships with oncology and malignant hematology regulatory reviewers at FDA, EMA, and other key Health Authorities

This role might be for you if...

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations.

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