Remote Director, Regulatory CMC — Global Submissions Leader

TG Therapeutics, Inc.; North Carolina; Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5–10 years of experience in Regulatory CMC, a strong technical background in relatorette methodologies, and the ability to manage multiple projects effectively. This role offers a hybrid work environment and opportunities for professional growth.

Qualifications

• 5–10 years of experience in Regulatory CMC in pharma or biotech.
• Strong background in analytical methods and quality control.
• Experience with biologics and combination products.

Responsibilities

• Coordinate regulatory filings with timely submissions.
• Draft responses to CMC-related questions from authorities.
• Maintain current knowledge of global regulatory requirements.

Skills

Technical CMC expertise

Regulatory compliance

Project management

Effective communication

Collaboration with CMOs

Education

BS in a scientific or engineering discipline

Advanced degree (MS, PhD, or PharmD)

Job description

A leading biopharmaceutical company is seeking an Associate Director/Director of Regulatory CMC to manage CMC functions and ensure compliance with global regulations. The ideal candidate has 5–10 years of experience in Regulatory CMC, a strong technical background in relatorette methodologies, and the ability to manage multiple projects effectively. This role offers a hybrid work environment and opportunities for professional growth.