Regulatory Affairs Specialist - Pharma & Combo Devices

BD; Vernon Hills (IL); Presencial; USD 118.000 - 189.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual Bonus

Potential Discretionary LTI Bonus

Medical coverage

Descripción de la vacante

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.

Formación

• Minimum BS required in science (Chemistry, Biology, Microbiology, or engineering). Masters preferred.
• Experience with NDA/ANDA/PAS/CBE submissions and CDER interactions is required.
• Strong knowledge of FDA and global regulatory requirements and 5+ years in Regulatory Affairs.

Responsabilidades

• Review CMC changes and determine regulatory reporting category per FDA guidance.
• Prepare domestic drug regulatory submissions (NDA, ANDA, PAS, CBE, IND, etc.).
• Define deliverables for regulatory submissions and coordinate across functions.
• Advise on regulatory strategy with R&D, Quality, Manufacturing and Marketing teams.
• Provide updates and strategy communication to Leadership.

Conocimientos

Regulatory submissions

FDA CDER liaison

Project management

Communication skills

MS Office

Educación

BS in science

Masters preferred

Herramientas

ERP systems

Electronic submissions platforms

Descripción del empleo

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.