Global Biologics CMC Regulatory Lead

Barrington James; Boston (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA requirements. This role requires a degree in a relevant field and 4+ years of experience in Regulatory Affairs CMC. Competitive compensation and opportunity for growth available.

Qualifications

• 4+ years of experience in Regulatory Affairs CMC.
• Understanding of biologics CMC development and regulatory principles.
• Experience authoring CMC modules for electronic submissions.

Responsibilities

• Lead preparation and submission of CMC documentation.
• Draft and compile CMC sections and responses to regulatory queries.
• Ensure compliance with regulatory requirements across development stages.

Skills

Regulatory Affairs CMC

Biologics CMC development

Collaboration with cross-functional teams

Strong organizational skills

Education

Degree in a relevant field

Job description

A public Biotech company in Boston is seeking a Regulatory Affairs CMC Manager/Senior Manager to support biologic products' global development and registration. The ideal candidate will lead the submission of regulatory documentation, ensuring compliance with FDA and EMA requirements. This role requires a degree in a relevant field and 4+ years of experience in Regulatory Affairs CMC. Competitive compensation and opportunity for growth available.