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 **Regulatory Affairs** in the **Clinical Domain**. 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**
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or related field
- 5+ years of experience in Regulatory Affairs, Clinical Development, or Regulatory Operations within Life Sciences
- Proven experience as a project manager, ideally in a consultancy or matrixed environment
- Strong knowledge of regulatory frameworks (FDA, EMA, ICH, GCP) and submissions processes
- Excellent communication, stakeholder management, and problem-solving skills
- PMP or similar project management certification is a plus
- Experience with digital tools supporting regulatory or clinical processes (e.g., Veeva Vault, eTMF, RIM systems) is a plus
- 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:

- Engage with stakeholders from Regulatory Affairs, Clinical Operations, Quality Assurance, and IT to define scope and objectives
- Translate regulatory requirements into actionable project plans, deliverables, and timelines
- Drive project execution, resource coordination, and risk management to ensure successful delivery
- Support clients in preparing for regulatory submissions, audits, and inspections
- Provide expertise on applicable US and international regulations (FDA, EMA, ICH, GCP, etc.)
- Contribute to the development of Epista’s consulting methodologies and internal knowledge base
- Act as a trusted advisor and thought partner to life science clients navigating complex regulatory challenges

**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.

**Location**:
, East Coast

Job type:
Full time

Application deadline:
As soon as possible

Employment date:
1. June 2025