Regulatory Affairs Manager — FDA Submissions & CMC Expert

Monte Rosa Therapeutics Inc.; Boston (MA); On-site; USD 85,000 - 110,000; Full time

Job summary

A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations. Candidates should have a Bachelor's/Master's degree in a scientific discipline and at least 8 years of Regulatory Affairs experience, particularly with CMC requirements for Small Molecule drugs. Strong knowledge of Microsoft Office applications is essential.

Qualifications

• Minimum 8 years of Regulatory Affairs experience.
• Extensive experience with CMC requirements for Small Molecule drugs.
• Prior experience compiling filings for FDA submissions.

Responsibilities

• Coordinate regulatory workflow and support project teams.
• Compile regulatory submissions and communicate with agencies.
• Research and analyze regulatory information.

Skills

Regulatory Affairs

Project Management

Analytical Thinking

Communication

Knowledge of CMC requirements

Education

Bachelor's/Master's Degree in a scientific discipline

Tools

Microsoft Office

Electronic publishing systems

Job description

A biotechnology company in Boston is seeking a Regulatory Affairs professional to coordinate and prepare document packages for regulatory submissions. The role involves providing regulatory support, preparing technical documents, and ensuring compliance with FDA regulations. Candidates should have a Bachelor's/Master's degree in a scientific discipline and at least 8 years of Regulatory Affairs experience, particularly with CMC requirements for Small Molecule drugs. Strong knowledge of Microsoft Office applications is essential.