Regulatory Scientist III
$94,900–$135,600 year
Remote · United States
Job Summary
Regulatory Scientist III is a senior-level, client-facing role leading regulatory strategy and execution for pre-approval, post-approval changes and lifecycle management across Rx and non-Rx programs. The position involves authoring, reviewing, and approving high-quality regulatory documents to align with global regulatory requirements, coordinating cross-functional teams to ensure complete submission content, mentoring junior staff, and supporting regulatory inspections. The role requires independent work, strong project management, and the ability to deliver submission-ready content while adhering to cGMP and ICH guidance. The position supports remote work from a home office and offers opportunities to guide strategic regulatory decisions and drive successful submissions for clients.
Required Qualifications
- Master's or Bachelor's in Chemistry, Analytical Chemistry or related life sciences (MS/BS preferred)
- Experience with cGMP regulations and ICH guidance
- Proficiency with Health Authority regulations (FDA, EMA, Health Canada) and global regulatory submissions
- Experience writing regulatory applications in eCTD format
- Strong written and verbal communication skills
- Ability to work independently in a client-facing role and mentor junior staff
- Proficiency with Microsoft Office Suite and Adobe Acrobat
- Ability to lead regulatory strategy and submission planning across pre- and post-approval changes
- Experience collaborating with cross-functional teams (CMC, Quality, Clinical, Supply Chain) and managing multiple tasks
- Knowledge of supplements, variations, responses to health authority queries
- Experience supporting regulatory inspections and responses
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