Regulatory Affairs Manager

Posted:
9/8/2025, 11:34:01 PM

Location(s):
Belgrade, Central Serbia, Serbia ⋅ Catalonia, Spain ⋅ Barcelona, Catalonia, Spain ⋅ Warsaw, Masovian Voivodeship, Poland ⋅ Prague, Czechia ⋅ Athens, Attica, Greece ⋅ Capital City of Prague, Prague, Czechia ⋅ Budapest, Budapest, Hungary ⋅ Bratislava, Region of Bratislava, Slovakia ⋅ Region of Bratislava, Slovakia ⋅ Budapest, Hungary ⋅ Masovian Voivodeship, Poland ⋅ Central Serbia, Serbia ⋅ Attica, Greece ⋅ Bucharest, Romania

Experience Level(s):
Senior

Field(s):
Legal & Compliance

At IQVIA Biotech, we partner with small to mid-sized biotech companies to bring life-changing therapies to patients faster. Our teams are agile, mission-driven, and deeply embedded in the science. If you're passionate about regulatory strategy and want to make a real impact, this is your moment.

About the Role
We’re looking for an experienced Regulatory Affairs professional to lead complex global projects and contribute to the development of breakthrough therapies. This is a high-impact, individual contributor role with autonomy and visibility across cross-functional teams.

Key Responsibilities:

  • Serve as Regulatory Team Lead or Project Manager on global submissions, guiding strategy and execution
  • Draft and review high-quality regulatory and technical documentation with minimal oversight
  • Engage directly with clients to resolve regulatory challenges and share insights—often representing the team independently
  • Manage project budgets, monitor scope, and ensure accurate revenue recognition
  • Provide informal mentorship and feedback to junior team members, supporting quality and consistency

Requirements:

  • Several years of hands-on experience in Regulatory Affairs within biotech, pharma, or CRO settings
  • Strong understanding of global regulatory requirements and submission pathways
  • Excellent technical writing and communication skills
  • Financial acumen and experience managing project budgets
  • A collaborative mindset and passion for innovation in biotech

Why IQVIA Biotech?

  • Work with cutting-edge biotech clients on first-in-class therapies
  • Flat structure and fast decision-making—your voice matters
  • Flexible working arrangements and a culture of inclusion
  • Competitive compensation, bonus schemes, and clear career growth pathways
  • Be part of a team that’s redefining what’s possible in clinical development

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com