CMC Regulatory Affairs Director – Global Submissions & Strategy

Omeros Corporation; Seattle (WA); On-site; USD 195,000 - 280,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) plan with company match

Three weeks of vacation

Twelve paid holidays

Job summary

A biotechnology company in Seattle is seeking a Director/Sr. Director for Regulatory Affairs focused on CMC. This role involves developing strategies, managing interactions with regulatory agencies, and ensuring compliance with submission standards. Ideal candidates will have 7+ years in regulatory CMC, a relevant degree, and strong analytical and leadership skills. Competitive compensation package offered, including benefits and stock options.

Qualifications

• Minimum of 7 years in regulatory CMC.
• Experience with major health agencies (FDA, Health Canada, EMA).

Responsibilities

• Develops regulatory CMC strategy.
• Implements strategy to advance projects.
• Drives content of CMC documentation.
• Coordinates with CMC, QA, and management.
• Leads interactions with regulatory agencies.

Skills

Regulatory CMC expertise

Analytical skills

Leadership skills

Communication skills

Organizational skills

Education

BS, MS, or PhD in chemistry or related discipline

Job description

A biotechnology company in Seattle is seeking a Director/Sr. Director for Regulatory Affairs focused on CMC. This role involves developing strategies, managing interactions with regulatory agencies, and ensuring compliance with submission standards. Ideal candidates will have 7+ years in regulatory CMC, a relevant degree, and strong analytical and leadership skills. Competitive compensation package offered, including benefits and stock options.