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Regulatory Affairs Specialist - FDA/CDER, Combo Products

vernon hills, IL

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About this opportunity

BD lists this Regulatory Affairs Specialist - FDA/CDER, Combo Products opportunity in vernon hills, Illinois. Review the employer’s description below for duties, qualifications and application requirements.

Job description

Becton Dickinson is seeking an experienced Regulatory Affairs professional in the United States to manage regulatory activities for combination devices and pharmaceuticals, including domestic submissions such as NDA/ANDA and labeling approvals.

The role involves coordinating with Marketing, R&D, Manufacturing, and Quality to ensure timely submissions and adherence to FDA guidance, with a focus on CDER regulatory requirements and quality systems.

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Worksite address

vernon hills, IL, 60061, US

Who can apply

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