Senior Regulatory Affairs Specialist - Pharma & Combination

Regulatory Jobs; Vernon Hills (IL); Presencial; USD 118.000 - 189.000; Tempo integral

Benefícios oferecidos por esta vaga

Annual Bonus

Discretionary LTI Bonus

Medical coverage

Dental coverage

Resumo da vaga

BD is seeking a Regulatory Affairs professional with 5+ years of experience in pharmaceuticals and/or combination products to manage regulatory activities for NDA/ANDA submissions and global requirements. This role interacts directly with FDA CDER and partners across R&D, Quality, Manufacturing, and Commercial teams.

The position supports on-site regulatory leadership in Vernon Hills, IL, with 10–20% travel, and offers a comprehensive benefits package and competitive compensation.

Qualificações

• 5+ years of Regulatory Affairs in Pharmaceuticals/ Combination Products with FDA CDER experience.
• Experience leading NDA/ANDA/PAS/CBE submissions and global regulatory requirements.
• Ability to manage complex regulatory projects with cross-functional partners.
• Strong knowledge of US/International regulations (21 CFR 820, ICH, ISO).
• Willingness to travel 10–20% and coordinate with multiple sites.

Responsabilidades

• Review CMC changes and determine regulatory reporting category per FDA guidance.
• Prepare domestic regulatory submissions (NDA, ANDA, PAS, CBE, IND).
• Define submission deliverables and coordinate cross-functional inputs.
• Collaborate with Marketing, R&D, Manufacturing, QA, and Medical Affairs on regulatory strategy.
• Provide updates and strategy to Leadership; ensure timely submissions.

Conhecimentos

Organizational skills

Communication skills

Independent work

Project management

Regulatory submissions

Attention to detail

Cross-functional collaboration

Formação

BS in science

Masters preferred

Ferramentas

MS Word

Excel

PowerPoint

Adobe Acrobat

Descrição da vaga

BD is seeking a Regulatory Affairs professional with 5+ years of experience in pharmaceuticals and/or combination products to manage regulatory activities for NDA/ANDA submissions and global requirements. This role interacts directly with FDA CDER and partners across R&D, Quality, Manufacturing, and Commercial teams.

The position supports on-site regulatory leadership in Vernon Hills, IL, with 10–20% travel, and offers a comprehensive benefits package and competitive compensation.