Manager, Regulatory Affairs

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

Overview

Responsible for the coordination and preparation of document packages for regulatory submissions ensuring compliance with the Food and Drug Administration (FDA) and international regulations/interpretations. May determine methods and procedures on some assignments and may provide guidance to other lower-level personnel.

Responsibilities

Coordinates regulatory workflow, provides regulatory support to the team, and tracks project timelines and budget.

Provides ongoing regulatory support to the project team members.

Under supervision, compiles regulatory submissions, license renewal and annual registrations to the US Food and Drug Administration (FDA) and other regulatory agencies.

Reviews and formats technical documents (pertaining to clinical, chemistry, manufacturing and controls, and non-clinical information). This may include the preparation of outlines, summaries, status reports, graphs, charts, tables and slides for distribution and communication to other departments.

Participates in assigned Regulatory Affairs initiatives aimed at improving internal Idenix standards and tracking/control systems.

Develops and maintains current regulatory knowledge and keeps abreast of regulatory procedures and changes.

Researches and analyzes regulatory information and determines acceptability of data, procedures, and other product-related documentation presented in support of product registration.

Direct interaction with regulatory agencies on routine matters.

Qualifications

Bachelors/Masters Degree in a scientific discipline or equivalent with a minimum 8 years of Regulatory Affairs experience.

Must have extensive experience and understanding of CMC requirements for Small Molecule drugs.

Prior experience compiling filings for FDA submissions is required with the ability to successfully manage projects to deadlines.

A working knowledge of electronic publishing and file management systems, preferred.

Excellent understanding of Microsoft Windows, Office, Excel, Project, Outlook, and other common PC applications.

Excellent organizational, presentation, and decision-making skills, and analytical thinking/problem-solving/investigative skills are required.

Certified regulatory affairs professional would be desirable