Director Combination Product Development

Director of Combination Product Development

We are currently looking to fill a Director of Combination Product Development role. In this position you will provide technical expertise to support and implement the strategic vision outlined by the senior leadership of Combination Products. This role is responsible for driving device and packaging development, ensuring alignment with Regeneron's therapeutic programs, and supporting clinical and commercial combination product manufacturing. The position involves collaboration with internal teams, external partners, and suppliers to advance device industrialization, regulatory compliance, and operational excellence.

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

• Collaborate with Combination Products senior leadership to revamp and execute Regeneron's combination product development strategies.
• Lead technical relationships with alliance partners, device manufacturers, component suppliers, and consultants, ensuring alignment and project success.
• Provide technical expertise to guide the development of devices, packaging, and accessories for therapeutic programs.
• Interface with internal teams, alliance partners, and suppliers to ensure effective communication, alignment, and project execution.
• Oversee the creation and maintenance of thorough documentation, including Design History Files, quality engineering data, human factors and usability study results.
• Provide expertise and documentation for regulatory filings, ensuring compliance with device design, manufacturing process controls, and quality risk management standards.
• Support device component manufacturing and clinical / commercial manufacturing of combination products.
• Provide technical support for qualification activities, assembly guidance, process controls, and risk assessments for Regeneron's internal fill-finish manufacturing operations.

This role may be a fit for you if you :

To be considered for this role you must hold a Bachelors degree in Science, Engineering, or related discipline and the following amount of experience :

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) $145,600.00 - $282,600.00