Director Combination Product Development

Director 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. A typical day may include:

• 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:

• Can manage responsibilities that may include directing device development engineers, project leaders, and team managers, encouraging professional growth and operational excellence.
• Are able to represent Regeneron in promoting device-related initiatives and integration across the organization.
• Can ensure work activities comply with applicable regulations and industry standards.
• Can represent Regeneron at industry meetings and forums, advocating for device-related advancements and partnerships.

To be considered for this role you must hold a Bachelor's degree in Science, Engineering, or related discipline and have:

• Associate Director: 10+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience.
• Director: 12+ years of experience in the pharmaceutical or medical device industry or equivalent combination of education and experience.

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.

Salary Range (annually): $145,600.00 - $282,600.00