Executive Director, Regulatory Affairs

This position provides an exciting opportunity to lead the work of a team advancing Regeneron’s vibrant pipeline in the area of general medicine within the Regulatory Strategy group in Regulatory Affairs.

The incumbent will lead a group of highly motivated individuals working to develop approaches to study candidate therapeutics in the area of general medicine with a focus in the area of cardiovascular and metabolic diseases including weight loss and muscle preservation products.

Experience with the successful advancement of products in the area of cardiovascular and metabolic diseases is preferred.

A strong interest in the science and biology of disease and disease prevention along with robust skills in the communication of scientific information are essential.

This is an opportunity to work in a highly dynamic, science-driven organization to advance the development of therapies to meet the needs of patients around the globe.

The position provides an opportunity not only to lead a team and to work with a cross-functional team supporting product development, but also to interact with senior managers in the company on regulatory strategies for product development.

Want to make an application Make sure your CV is up to date, then read the following job specs carefully before applying.

This management position in Regulatory Affairs involves the ability to lead and manage a Therapeutic Area (TA) within Regeneron’s Regulatory Affairs organization so that all corporate objectives are met within specified timelines and so that the necessary state of compliance is maintained relative to all regulatory commitments / requirements.

In addition the position assists corporate senior management in understanding Regulatory strategies / processes while developing corporate objectives and, importantly, understanding the impact of decisions across functional areas.

In this role, a typical day might include the following :

• Responsible for regulatory strategies for development programs in the assigned TA to ensure Regulatory Agency approval(s) within specified timelines of all activities in support of Regeneron’s corporate development and marketing objectives.
• Manages liaisons and / or provides direction to regulatory representatives to project teams who effect and communicate regulatory strategies.
• Review critical regulatory communications. Evaluate conformance with the regulatory requirements, clarity, and completeness.
• Responsible for ensuring necessary state of compliance for all regulatory commitments / requirements :
• Supervises / manages others to ensure that all reporting requirements and other commitments are met with respect to INDs, BLAs, CTA etc.
• Supports liaisons with their project specific communications, including Agency meetings.
• Responsible for the completeness and accuracy of information provided in regulatory submissions.
• Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
• Responsible for the planning, preparation and submission of licensing applications.
• Manages liaisons and / or provides direction to regulatory representatives to project teams who effect and communicate to multidisciplinary teams the content, format, style architecture and timing of a Biologics Licensing Application (BLA).
• Review application. Evaluate conformance with the regulatory requirements, clarity, and completeness.
• Supervise Regulatory staff with respect to commercialization activities associated with new product registrations.
• Responsible to senior management for timelines / budgets.
• Continually monitor newly published FDA guidelines and international guidance documents in the context of new and ongoing development programs.

Provide training on applicable requirements for scientific staff as required.

This role might be for you if you meet the following criteria :

• Minimal educational requirements : Ph.D., PharmD, or MD.
• 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.
• Must possess excellent written and verbal communication skills.

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.

Salary Range (annually) : $275,800.00 - $459,600.00

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