Senior Regulatory Affairs Lead (Contract) – FDA & CMC

Curium Pharma; St. Louis (MO); On-site; USD 80,000 - 100,000; Full time

Job summary

Curium Pharma in St. Louis, MO, is seeking a Senior Regulatory Affairs Specialist. This role involves supporting US FDA applications and coordinating regulatory activities to ensure compliance with health authorities.

The ideal candidate should possess a Bachelor's degree in a scientific discipline and have over 5 years of regulatory experience. Strong attention to detail and excellent communication skills are essential. Opportunity to work in a dynamic environment.

Qualifications

• 5+ years of Regulatory experience or related field.
• Project leadership or supervisory experience preferred.
• Use of software system to manage change controls.

Responsibilities

• Support US FDA applications (NDAs, ANDAs, DMFs).
• Plan and compile statutory reports in eCTD format.
• Review and assess regulatory impact for CMC changes.

Skills

Regulatory experience

Attention to detail

Excellent communication skills

Problem-solving

Organizational skills

Education

Bachelor Degree in scientific discipline or equivalent work experience

Tools

Microsoft Office

Adobe Acrobat

Job description

Curium Pharma in St. Louis, MO, is seeking a Senior Regulatory Affairs Specialist. This role involves supporting US FDA applications and coordinating regulatory activities to ensure compliance with health authorities.

The ideal candidate should possess a Bachelor's degree in a scientific discipline and have over 5 years of regulatory experience. Strong attention to detail and excellent communication skills are essential. Opportunity to work in a dynamic environment.