Vice President, Regulatory Affairs Strategy- Oncology & Hematology

Overview

Vice President, Regulatory Affairs Strategy- Oncology & Hematology. Leads a group within Regeneron’s Regulatory Affairs organization, providing guidance to Research, Regeneron Genetics Center, Regeneron Cellular Medicine, and the Oncology and Hematology Clinical Development Units on regulatory strategies for the development of Oncology & Malignant Hematology drug products to meet corporate objectives within timelines and maintain compliance. Serves as a trusted advisor to senior management regarding regulatory strategies and processes, while shaping organizational objectives and understanding cross-functional impacts.

As a strategic leader, the incumbent will help evolve Regeneron’s Oncology & Hematology medicine development candidates by leveraging cross-functional relationships and by leading the development of a highly functioning department to meet current and anticipated demands.

Responsibilities

• Drive decision making on regulatory strategies for development of Oncology & Malignant Hematology product candidates to ensure regulatory agency approvals within specified timelines, supporting organizational development and marketing objectives.
• Design regulatory communication strategy for Oncology & Malignant Hematology product candidates and align liaison for projects and 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.
• Lead and manage liaisons and/or provide direction to regulatory representatives and project teams collaborating with multidisciplinary teams on content, format, style, architecture, and timing of regulatory submissions.
• Evaluate applications for conformance with 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.

Qualifications

• This role may be for you if you have a terminal degree (MD, PhD, PharmD, etc.) in a scientific discipline related to Medicine, Pharmacology, Physiology, Biochemistry, Molecular Biology, or related fields, or have actively conducted research in a related field, or possess other practical experience related to Oncology & Malignant Hematology.
• A minimum of 15 years of pharmaceutical industry or related experience, with at least 5 years in regulatory affairs.
• Research laboratory, process development, or manufacturing experience with biotechnology products is highly desirable.
• Business-oriented, with experience working closely with commercial and development partners.
• Experience in setting and implementing functional strategy; proven leadership of development professionals in a scientifically oriented environment.
• Strong communication skills and demonstrated ability to influence and listen across forums.
• Fosters a collaborative, innovative, problem-solving culture and develops high-performing staff.

Compensation and Employment Details

Salary Range (annually): $300,000.00 - $500,000.00

Seniority level: Executive

Employment type: Full-time

Job function: Legal

Industries: Internet News

EEO and Benefits

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, disability, genetic information, familial 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. The Company will provide reasonable accommodation to known disabilities or chronic illnesses where an applicant is otherwise qualified, unless the accommodation would impose undue hardship on operation of the Company's business.

Please note that background checks may form part of the recruitment process as required by law in the country of the position.

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