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BD

Regulatory Affairs Specialist - Pharma & Combo Devices

vernon hills, IL

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About this opportunity

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

Job description

BD is seeking an experienced Regulatory Affairs professional to manage regulatory activities for combination devices and/or pharmaceuticals, including NDA/ANDA/PAS/CBE submissions. The ideal candidate has 5+ years of regulatory experience, strong FDA CDER interaction, and the ability to lead complex projects across R&D, Quality, Manufacturing, Medical Affairs, and Commercial teams.

The role requires independent work, excellent organization, and proactive cross-functional collaboration.

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Worksite address

vernon hills, IL, 60061, US

Who can apply

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