Regulatory Submissions Lead — FDA & Global

Monte Rosa Therapeutics; Boston (MA); On-site; USD 85,000 - 115,000; Full time

Job summary

A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs, and a strong understanding of CMC requirements. Key responsibilities include managing submissions to the FDA, providing regulatory support to teams, and ensuring compliance with relevant regulations. Excellent communication and organizational skills are essential.

Qualifications

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

Responsibilities

• Coordinates regulatory workflow and tracks project timelines.
• Provides regulatory support to project team members.
• Compiles regulatory submissions to the FDA and other agencies.

Skills

Regulatory Affairs expertise

Project management

Analytical thinking

Knowledge of regulatory requirements

Communication skills

Education

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

Tools

Microsoft Office

Electronic publishing systems

Job description

A biopharmaceutical company in Boston is seeking a Regulatory Affairs Specialist to coordinate the preparation of regulatory submission packages. The ideal candidate will have at least 8 years of experience in Regulatory Affairs, particularly with Small Molecule drugs, and a strong understanding of CMC requirements. Key responsibilities include managing submissions to the FDA, providing regulatory support to teams, and ensuring compliance with relevant regulations. Excellent communication and organizational skills are essential.