Project Manager, Regulatory Affairs

At Epista, we are redefining what excellence looks like in the life science industry. As trusted advisors to some of the world’s leading pharma, biotech, and medtech companies, we combine regulatory insight with deep domain expertise to drive performance. Our mission? To define and deliver process, technology, and compliance excellence—empowering our clients to bring life-changing therapies to market faster, safer, and smarter. Since our founding, we’ve expanded into multiple countries with big ambitions for the future. Our team is our superpower – If you're interested in being part of the Epista Journey, today!

We are expanding our US presence and seeking a dynamic and experienced Project Manager to lead initiatives within IT Regulatory Affairs. You will collaborate with clients and cross-functional teams to deliver critical projects that bridge business needs, compliance, and operational performance. This is a unique opportunity to join a fast-growing, entrepreneurial consulting firm where your impact will be both immediate and lasting.

• Facilitate standardization of processes across business units to ensure consistency
• Remove obstacles and optimize communication flow between stakeholders and implementation teams
• Prepare decision gate activities and provide regular status updates to leadership
• Ensure compliance with regulatory requirements and quality standards for all deployed solutions
• Lead change management activities to support successful adoption of the new centralized model

• Prior experience working with Pharmaceutical or Biotechnology companies
• Strong project management experience with demonstrated ability to manage complex, cross-functional initiatives
• Clear understanding of business objectives and ability to make decisive recommendations
• Experience with project management tools (ServiceNow PPM, Jira)
• Excellent stakeholder management and communication skill
• Must be eligible to work in the US without sponsorship

As an Epista Consulting Project Manager, you’ll be working at the intersection of compliance and business as a part of our highly skilled and dedicated team. You’ll be involved in a wide variety of projects, primarily focusing on the Regulatory and Clinical Domain. Much of your time will be spent with our clients - international pharma and medical technology companies. Your daily activities might include:

• Coordinate cross-functional project teams (internal and external resources) to implement centralized hub operations
• Manage day-to-day delivery, scope, schedule, and resources for the centralization initiative
• Monitor project KPIs and track implementation progress against established timelines
• Identify, monitor, and manage risks with appropriate mitigation plans throughout the project lifecycle

What We Offer

• A values-driven, collaborative team environment
• Opportunities for career growth and continuous learning
• The chance to work with top-tier clients and industry leaders
• Competitive compensation and benefits
• Flexibility to work remotely within the US

Epista is a team of pioneers. We unlock each consultant’s potential to continuously improve. We pioneer new ways to stay in control of patient safety and product quality and question the status quo in everything we do.

Our unique team spirit makes a positive impact – on our clients and the Life Science industry. Here, you’re never alone. We all work together for everyone’s success. And each individual is strengthened by the knowledge of the group.

We’re proud to #beEpista

Epista is an equal opportunity employer and value diversity. All employment is decided on the basis of qualifications, merit and business need.