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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...

+ Advanced degree in a scientific discipline related to Medicine, Pharmacology, Physiology, Biochemistry, Molecular Biology or other disciplines related to the job OR actively having done research in a related field OR having other specific practical experience related to Oncology & Malignant Hematology.

+ A minimum of 15 years of pharmaceutical industry or related experience, at least 5 of which should include regulatory experience.

+ Research laboratory, process development or manufacturing experience with biotechnology products highly desirable.

+ Be business orientated, worked closely with commercial and development partners.

+ Determined a functional strategy and have implemented it successfully.

+ Have significant experience leading other development professionals in a scientifically oriented environment.

+ Be an outstanding communicator in all forums. Demonstrating the ability to influence and listen to others

+ Fosters a collaborative, innovative, problem-solving culture and mind-set and develops high performing staff

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$300,000.00 - $500,000.00