Regulatory Affairs Sr Manager

Scorpion Therapeutics; Illinois; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Stock; retirement plan

Medical, life and disability insurance

Bonus eligibility

Job summary

Scorpion Therapeutics is seeking a Regulatory Affairs Senior Manager to lead CMC regulatory strategies for investigational and marketed products, aligning with corporate objectives.

You will coordinate CMC submissions, develop risk registers, and guide regulatory documents for Health Authority meetings to enable approvable reviews.

This role requires a Master’s degree in regulatory field with 6+ years of experience, FDA knowledge, and cross-functional project management skills.

Qualifications

• Master's degree in regulatory science or related field with 6 years of regulatory experience.
• Experience leading interactions with Regulatory Agencies and preparing submissions.
• Proficient with CMC content development and review for clinical and marketing applications.

Responsibilities

• Formulate and present CMC regulatory strategies across products.
• Develop risk registers for major regulatory submissions.
• Coordinate preparation of CMC components of submissions.
• Prepare CMC documents for submissions and health authority meetings.
• Develop responses to CMC topics with health authorities.
• Review change controls and provide regulatory impact assessments.
• Ensure compliance with health authority expectations and guidelines.

Skills

CMC regulatory

Regulatory submissions

Health Authority liaison

Veeva Vault

Regulatory strategy

Project management

Education

Master's degree in regulatory science or related field

Job description

Regulatory Affairs Sr Mgr

Responsibilities

• Formulate and present CMC regulatory strategies aligned with corporate objectives across investigational and marketed products.
• Develop risk registers for major regulatory submissions, including mitigation proposals.
• Coordinate preparation of CMC components of regulatory submissions.
• Guide and contribute to CMC-related documents for regulatory submissions, Health Authority meeting requests, and briefing books to meet regulatory standards and be approvable on first review cycle.
• Develop strategies and prepare responses to CMC-related topics with health authorities.
• Review manufacturing/testing change controls and provide regulatory impact assessments.
• Represent and support CMC regulatory on multidisciplinary project teams; provide CMC regulatory guidance.
• Ensure compliance with Health Authority expectations and regulatory guidance.
• Maintain and communicate knowledge of current/emerging CMC regulatory environments, guidelines, and best practices.

Requirements

• Master's degree (or foreign equivalent) in Regulatory Science, Environmental, Safety and Health management or related field + 6 years' experience in the job offered or in an Associate or regulatory-related occupation.
• 6 years' experience in:
  • Leading interactions with Regulatory Agencies (briefing documents, meeting logistics).
  • Organizing/preparing/reviewing CMC content for clinical trial or marketing applications.
  • Compiling CMC quality data using Veeva Vault.
  • Developing/ managing project timelines and deliverables.
  • Knowledge of international drug-development standards (GLP, GCP, GMP).
  • Knowledge of FDA organization, roles, and responsibilities for drug development.
  • Analyzing, summarizing, and interpreting scientific data considering limitations.

Benefits

• Stock; retirement; medical, life and disability insurance; eligibility for annual bonus or other incentive compensation (per job posting).