Manager, Regulatory Affairs - Project Management

BioSpace; Bridgewater (MA); On-site; USD 119,000 - 168,000; Full time

Job summary

A global biopharmaceutical company is seeking a Manager for Regulatory Affairs - Project Management. The role involves coordinating regulatory submissions, managing projects, and ensuring compliance with global regulations. Ideal candidates will have a background in life sciences and extensive experience in regulatory affairs. Join a company recognized for its commitment to diversity and employee satisfaction.

Benefits

Flexible work arrangements

Health benefits and paid time off

Competitive compensation

Bonuses

Equity and stock plans

Qualifications

• 5+ years in regulatory affairs.
• Project management experience in pharma or regulatory environment.

Responsibilities

• Coordinate post-submission activities with Regulatory colleagues.
• Create and maintain a Global Submission Plan.
• Ensure adherence to global regulatory regulations.

Skills

Project Management

Communication

Organizational Skills

Leadership

Education

Bachelor's Degree in life sciences or chemistry

Tools

Smartsheet

Microsoft Office

Veeva Vault RIM

Job description

Manager, Regulatory Affairs - Project Management

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Position Overview

Insmed is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. We value our employees and are committed to a patients-first approach. We seek talented individuals worldwide who challenge the status quo, solve problems, and collaborate with urgency and compassion.

Company Highlights

• Ranked as Science's Top Employer for four consecutive years
• Certified Great Place to Work in the U.S. for four years
• Awarded for diversity and workplace excellence

Responsibilities

• Coordinate post-submission activities with Regulatory colleagues, including FDA meetings and rehearsals
• Perform scenario planning for multiple regulatory strategies to meet accelerated timelines
• Create and maintain a Global Submission Plan detailing dossier content, activities, and timelines
• Lead submission planning discussions, ensuring clarity on deliverables and responsibilities
• Apply in-depth knowledge of global regulatory submission requirements, processes, and systems
• Manage coordination of submission documents for global projects in eCTD format
• Supervise timely delivery of submission components and coordinate publishing activities
• Ensure adherence to global regulatory regulations and guidelines
• Demonstrate strong project management and organizational skills to handle multiple projects

Position Requirements

• Bachelor's Degree in life sciences or chemistry; 5+ years in regulatory affairs
• Project management experience in pharma or regulatory environment, proficiency with Smartsheet or similar tools
• Knowledge of global regulatory processes from pre-IND to Phases I-IV
• Excellent communication, organizational, and leadership skills
• Experience with Veeva Vault RIM, Smartsheet, Microsoft Office
• Ability to work effectively in a diverse, dynamic workplace
• Commitment to continuous improvement and innovation

Salary Range

$119,000 - $167,267 per year

Benefits

• Flexible work arrangements
• Health benefits and paid time off
• Competitive compensation, bonuses, equity, and stock plans

Additional Information

Insmed is an Equal Opportunity Employer. We provide accommodations for applicants with disabilities. For accommodation requests, contact [e-mail]. Applications are accepted for 5 days from posting or until filled.