Sr Manager/Assoc Director, CMC Regulatory Affairs

Responsibilities

• Provide CMC regulatory support through quality control review of submission components
• Prepare and review regulatory documents for product development and compliance
• Evaluate proposed CMC changes and develop global regulatory filing strategies
• Collaborate on eTMF processes and ensure compliance alignment
• Serve as a regulatory representative on study and program teams
• Lead development of global regulatory submissions and respond to regulatory inquiries
• Review clinical and CMC documents for compliance and consistency

Qualifications

• Undergraduate degree required; advanced degree preferred
• 5+ years in pharmaceutical or biotech regulatory affairs, especially for oncology products
• Ability to translate regulatory requirements into actionable plans
• Experience in developing systems and processes for efficient document submissions
• Strong organizational skills with attention to detail
• Prominent relationship-building abilities across diverse teams
• Demonstrated skills in achieving performance goals in dynamic environments
• Effective communication and teamwork capabilities, with a proactive mindset

Benefits

• Comprehensive medical, dental, and vision plans
• Paid Time Off, holiday, and sick leave
• Short- and long-term disability coverage
• 401(k) plan with company contribution
• Flexible Spending Accounts (FSA, HSA, and commute)
• Pet insurance and employee assistance program
• Annual bonus and equity grant opportunities