Remote Senior Manager, CMC Regulatory Affairs

NewAmsterdam Pharma Company; United States; On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Health insurance

Dental and vision coverage

Retirement plans

Job summary

NewAmsterdam Pharma Company is looking for a Senior Manager, CMC Regulatory Affairs to support global regulatory strategies for clinical and commercial products. The role requires at least 8 years of pharmaceutical experience, including regulatory submissions like INDs and NDAs.

This remote position involves collaboration with multiple cross-functional teams and providing support for regulatory inspections and commitments. A comprehensive benefits package is included alongside a competitive salary.

Qualifications

• 8 years in the pharmaceutical industry, with a minimum of 6 years in Regulatory.
• Proven experience supporting CMC regulatory submissions.
• Experience supporting global regulatory filings.

Responsibilities

• Support development and execution of global CMC regulatory strategies.
• Lead post-approval CMC regulatory lifecycle management activities.
• Ensure timely delivery of high-quality regulatory packages.

Skills

Experience with CMC regulatory submissions

Strong project management and organizational skills

Knowledge of FDA regulations and ICH guidelines

Excellent verbal and written communication skills

Education

Bachelor's degree in a scientific discipline

Advanced degree preferred

Tools

Electronic document management systems

Regulatory information management tools

Job description

NewAmsterdam Pharma Company is looking for a Senior Manager, CMC Regulatory Affairs to support global regulatory strategies for clinical and commercial products. The role requires at least 8 years of pharmaceutical experience, including regulatory submissions like INDs and NDAs.

This remote position involves collaboration with multiple cross-functional teams and providing support for regulatory inspections and commitments. A comprehensive benefits package is included alongside a competitive salary.