Regulatory Affairs Specialist – Pharma & Devices

Regulatory Jobs; Vernon Hills (IL); On-site; USD 118,000 - 189,000; Full time

Benefits offered by this job

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Health Savings Accounts

Flexible Spending Accounts

Dental coverage

Vision coverage

Life and AD&D insurance

Paid time off

Job summary

BD is seeking a Regulatory Affairs professional to manage regulatory activities for new and existing combination devices and/or pharmaceuticals. The ideal candidate will have 5+ years of experience, strong interaction with FDA CDER, and a proven track record in NDA/ANDA/PAS submissions, with the ability to lead complex regulatory projects cross-functionally.

Responsibilities include drafting submissions, ensuring regulatory compliance, maintaining drug registrations, and supporting labeling

Qualifications

• BS in science (Chemistry/Biology/Pharma) required; Masters preferred.
• 5+ years of Regulatory Affairs experience with combination products/pharma.
• Experience with NDA/ANDA/PAS/CBE submissions and FDA CDER interactions.

Responsibilities

• Review regulatory requirements and determine submission deliverables.
• Prepare domestic regulatory submissions (NDA, ANDA, PAS, CBE, IND, etc.).
• Collaborate with Marketing, R&D, Manufacturing, and Quality on regulatory strategy.

Skills

Regulatory submissions

FDA CDER interaction

Project management

Communication skills

Attention to detail

Education

BS in science

Masters preferred

Tools

FDA databases

MS Office

ERP systems

Job description

BD is seeking a Regulatory Affairs professional to manage regulatory activities for new and existing combination devices and/or pharmaceuticals. The ideal candidate will have 5+ years of experience, strong interaction with FDA CDER, and a proven track record in NDA/ANDA/PAS submissions, with the ability to lead complex regulatory projects cross-functionally.

Responsibilities include drafting submissions, ensuring regulatory compliance, maintaining drug registrations, and supporting labeling