Global Regulatory CMC Lead

Hydrogen Group; Boston (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in the pharmaceutical industry. Responsibilities include managing Health Authority interactions and leading cross-functional teams. This position is vital for ensuring successful product submissions and regulatory compliance.

Qualifications

• 3-5 years relevant experience in the pharmaceutical industry or regulatory authority with CMC review.
• Expertise in authoring CMC submission documents.
• Experience in pharmaceutical manufacturing or quality assurance/control.

Responsibilities

• Provide strategic and operational Regulatory CMC expertise in cross-functional teams.
• Prepare regulatory submissions for products in assigned regions.
• Manage routine and non-routine Health Authority interactions.

Skills

Leadership

Cross-functional collaboration

Regulatory CMC knowledge

Strong communication

Interpersonal skills

Job description

A global healthcare firm is seeking a Regulatory CMC Lead in Boston, MA. The role requires expertise in regulatory strategy, operations, and planning for CMC aspects of assigned projects. Candidates should possess strong communication skills and a minimum of 3-5 years in the pharmaceutical industry. Responsibilities include managing Health Authority interactions and leading cross-functional teams. This position is vital for ensuring successful product submissions and regulatory compliance.