Senior Manager/Manager, Regulatory Affairs

Scorpion Therapeutics; Germantown (MD); On-site; USD 120,000 - 180,000; Full time

Job summary

Scorpion Therapeutics in Germantown, MD seeks an Associate Director/Senior Manager, Regulatory Affairs to support global drug development and regulatory strategies. Based in Germantown, this role liaises with FDA and international agencies, develops and executes regulatory plans, and contributes to IND/BLA preparation.

You will review technical documentation, monitor evolving regulations, and collaborate with quality, CMC, preclinical, and clinical teams to ensure compliance and risk mitigation.

Qualifications

• Bachelor's degree in life sciences (advanced degree preferred).
• 5+ years in biotech/pharma regulatory affairs.
• Deep knowledge of global regulations.
• Experience with eCTD submissions.

Responsibilities

• Manage daily regulatory activities for investigational and commercial drugs.
• Serve as liaison with FDA and international agencies.
• Develop and execute regulatory strategies aligned with development and marketing goals.
• Contribute to IND/BLA preparation.
• Review technical documentation.
• Monitor evolving regulations.
• Collaborate with cross-functional teams across quality, CMC, preclinical, and clinical programs to ensure compliance and risk mitigation.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Education

Bachelor's degree in life sciences (advanced degree preferred)

Tools

eCTD submissions

Job description

Role

Associate Director/Senior Manager, Regulatory Affairs, based in Germantown, MD, supporting global drug development and regulatory strategies.

Responsibilities

• manage daily regulatory activities for investigational and commercial drugs
• serve as liaison with FDA and international agencies
• develop and execute regulatory strategies aligned with development and marketing goals
• contribute to IND/BLA preparation
• review technical documentation
• monitor evolving regulations
• Collaborate with cross-functional teams across quality, CMC, preclinical, and clinical programs to ensure compliance and risk mitigation

Qualifications

• bachelor's degree in life sciences (advanced degree preferred)
• 5+ years in biotech/pharma regulatory affairs
• deep knowledge of global regulations
• experience with eCTD submissions

High Value

• regulatory strategy for biologics/pharmaceuticals
• IND/BLA submissions
• global compliance
• cross-functional collaboration
• risk management

Work Setup

office-based with some lab and manufacturing access; some travel required.