Regulatory Affairs CMC Senior Manager/Associate Director - Remote

Overview

The Regulatory Affairs CMC Senior Manager/Associate Director will be responsible for planning and executing the CMC regulatory strategies for assigned development programs. You will partner with CMC technical leads, Quality Assurance, and other technical areas to develop optimized plans for successful regulatory submissions.

In Short

• Actively participate on CMC development teams to plan regulatory strategies.
• Align CMC regulatory plans with cross-functional development and manufacturing teams.
• Execute regulatory strategies and manage progress within defined timelines.
• Articulate complex CMC regulatory issues to project teams and stakeholders.
• Write Module 3 sections to support INDs, IMPDs, NDAs, and MAAs.
• Evaluate health authority questions and lead responses.
• Write questions and briefing documents for Health Authority meetings.
• Evaluate manufacturing and quality changes for regulatory impact.
• Facilitate development and review of CMC documentation for submissions.
• Disseminate global CMC regulations and guidelines.

Requirements

• Minimum of BS or BA in a scientific or technical discipline.
• 8 years of industry experience, with at least 5 years in regulatory affairs.
• Thorough understanding of drug development and regulatory requirements.
• Proven track record in a biotech start-up environment.
• Expertise in navigating matrixed organizations.
• Experience with Veeva Vault is a plus.

Benefits

• 99% premium cost covered for medical, dental, and vision plans.
• Bonus program structured to pay quarterly.
• 401k plan with 100% match up to 6% of employee’s contribution.
• Wellness benefit of $200/month for flexible options.
• Unlimited PTO and generous family leave benefits.
• Eligibility for equity awards and Employee Stock Purchase Plan.