Director Combination Product Development

Regeneron Pharmaceuticals • Valley, AL

99d • $145,600 - $282,600

About The Position

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.

Requirements

• Bachelor's degree in Science, Engineering, or related discipline.
• 10+ years of experience in the pharmaceutical or medical device industry for Associate Director role.
• 12+ years of experience in the pharmaceutical or medical device industry for Director role.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• Health and wellness programs
• Fitness centers
• Equity awards
• Annual bonuses
• Paid time off for eligible employees

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees