Senior Manager, CMC Regulatory Affairs - Small Molecules

This role will provide business-aligned guidance focused on governance, compliance, and operational risk management. You will partner with leaders, compliance stakeholders, and cross-functional teams to translate complex issues into practical recommendations. The position offers the opportunity to strengthen responsible execution, improve decision-making, and support sustainable growth within a life sciences environment.

Location: Remote - US based candidates only, no visa sponsorship available

Responsibilities

• Develop and execute CMC regulatory strategies for small molecule pharmaceuticals
• Lead cross-functional teams to provide regulatory guidance during product development
• Assess regulatory risks and recommend mitigation strategies
• Prepare and submit CMC documentation for regulatory filings, including INDs and NDAs
• Coordinate contributions to CMC submissions to ensure compliance with regulations

Requirements

• Bachelor's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biology, Biochemistry, or related field; advanced degree preferred
• 7+ years of Regulatory Affairs experience in pharmaceutical or biotechnology, with a focus on CMC
• Significant experience with small molecule products from IND through commercialization
• Experience preparing and managing various CMC regulatory submissions, such as INDs, CTAs, and NDAs
• Strong collaboration skills across cross-functional teams in development and commercial environments

Benefits

• Premium health, financial, work-life, and well-being offerings for employees and dependents
• Wellness and employee support programs
• Life insurance and disability coverage
• Retirement plans with employer match
• Generous paid time off

Pay

$132,000 – $172,000 annually