Manager, Regulatory Affairs

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

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

• Bachelor's/Master's 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.