Project Manager - (Hybrid)

Project Manager (RIM / Regulatory IT)

Position: Project Manager
Location: Richmond, VA (Hybrid)
Pay Rate: $137.00 per hour
Contract Type: Temporary (12‐month duration)
Work Arrangement: Hybrid

Job Overview

We are seeking an experienced Project Manager with deep expertise in Regulatory Information Management (RIM) and the life sciences industry to lead strategic regulatory technology initiatives.

This role will oversee the implementation of RIM platforms, manage cross-functional stakeholders, ensure regulatory compliance, and drive adoption of enterprise regulatory solutions across global teams.

The ideal candidate brings strong pharmaceutical, biotech, or medical device industry experience and has a proven track record leading large-scale regulatory IT projects.

Required Skills

Domain Expertise

• Deep knowledge of regulatory submission processes
• Experience working with global health authority requirements, including:
• • FDA
  • EMA
  • PMDA
• Strong understanding of regulatory operations and compliance requirements
• Technical Acumen
  

Experience implementing and supporting Regulatory Information Management (RIM) platforms, including:

• • Ennov
  • Veeva Vault RIM
  • OpenText

Understanding of regulatory data governance and submission management processes

Change Management

• Proven ability to drive user adoption and organizational change
• Experience supporting global life sciences users through technology transformations
• Strong stakeholder engagement and communication skills
  

Project Methodology

• PMP certification preferred
• Agile certification preferred
• Scrum methodology experience preferred
• Strong project governance and delivery experience
  

Qualifications

Education. Bachelor's Degree in:

• • Computer Science
  • Life Sciences
  • Information Technology
  • Related field
    

Experience

• 8 years of IT Project Management experience
• 5 years of experience within pharmaceutical, biotechnology, or medical device regulatory IT environments
• Experience leading enterprise software implementation projects
• Experience managing global cross-functional teams and vendors

Core Responsibilities

Project Delivery

• Lead end-to-end implementation of RIM modules, including:
• • Registrations
  • Submissions
  • Dossier Management
  • IDMP
• Manage project planning, execution, monitoring, and delivery
• Ensure successful project outcomes within scope, budget, and timeline
  

Stakeholder Management

• Partner with:
• • Regulatory Operations
  • Quality Assurance
  • Research & Development (R&D)
  • Business Leadership
• Gather business requirements and translate them into technology solutions
• Facilitate communication between business and technical teams
  

Compliance & Validation

• Oversee GxP Computer System Validation (CSV)
• Ensure compliance with regulatory requirements and company standards
• Support data integrity and compliance initiatives
• Manage system validation documentation and testing activities
  

Resource & Vendor Management

• Manage project scope and resource allocation
• Coordinate internal teams and external vendors
• Monitor project budgets and delivery performance
• Ensure effective utilization of project resources
  

Risk Management

• Track milestones, deliverables, and dependencies
• Identify project risks and technical bottlenecks
• Develop and execute mitigation strategies
• Provide project status updates to leadership and stakeholders
  

Top 3 Priority Skills

1. Regulatory Domain Expertise

• Deep knowledge of global regulatory submission processes
• Experience working with FDA, EMA, and PMDA requirements

2. RIM Platform Experience

• Hands-on experience with RIM platforms
• Strong preference for Ennov experience

3. Change Management

• Proven ability to drive adoption of regulatory technologies
• Experience leading organizational transformation initiatives within life sciences organizations

Ideal Candidate Profile

We are looking for someone who:

• Has extensive pharmaceutical or biotech project management experience
• Understands regulatory operations and submission processes
• Has led RIM implementation projects
• Thrives in highly regulated environments
• Can effectively manage stakeholders at all organizational levels
• Successfully drives change and user adoption across global teams

Who We Are
SGF Global is an integrated talent solutions provider, offering staffing, recruitment, Employer of Record (EOR), nearshore, and consulting services across a wide range of industries in 35 countries. We're a dynamic, people-first organization where fresh ideas are always welcome. Our culture is built on collaboration, innovation, and a genuine passion for helping people grow. At SGF Global, smiles are part of the dress code, and every voice matters.

Are you looking to join an organization where your ideas are valued, your growth is supported, and your work makes a global impact?

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