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Greenwood Village, Colorado

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Director, Regulatory Affairs - Combination Products (Remote)
Job Summary: The Director, Regulatory Affairs serves as the global regulatory lead for combination products and RA business development. This role serves as a key strategic partner with the development and commercial teams and works closely with the broader regulatory matrix team to conceive and deliver successful registration and life-cycle management of standard and technologically complex combination products. The Director will lead cross-functional internal activities and work directly with external customers and health authorities to plan and assist with ANDA, NDA, BLA, and OUS Marketing Applications. This role is responsible for driving continuous improvement in the day-to-day operations of product development and Regulatory Affairs, seeking opportunities t


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