Regulatory Affairs Manager, FDA Submissions

Monte Rosa Therapeutics, Inc; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams.

The ideal candidate holds a Bachelors/Masters in a scientific discipline with at least 8 years of relevant experience. Strong knowledge of CMC requirements and excellent organizational skills are essential. The position involves direct interaction with regulatory agencies and is critical to the success of regulatory initiatives.

Qualifications

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

Responsibilities

• Coordinate regulatory workflow and provide support to the team.
• Compile regulatory submissions and manage project timelines.
• Research regulatory information and interact with regulatory agencies.

Skills

Regulatory Affairs expertise

Project management

Analytical skills

Knowledge of CMC requirements

Education

Bachelors/Masters Degree in a scientific discipline

Tools

Microsoft Office Suite

Job description

Monte Rosa Therapeutics, Inc is seeking an experienced regulatory affairs professional in Boston, MA. Responsibilities include coordinating regulatory workflows, compiling submissions to the FDA, and providing ongoing support to project teams.

The ideal candidate holds a Bachelors/Masters in a scientific discipline with at least 8 years of relevant experience. Strong knowledge of CMC requirements and excellent organizational skills are essential. The position involves direct interaction with regulatory agencies and is critical to the success of regulatory initiatives.