Manager, Regulatory Affairs

il y a 4 jours

Courbevoie, Île-de-France IQVIA Temps plein

About IQVIA
IQVIA is a global leader in healthcare intelligence, committed to defining and delivering the future of healthcare. Our brand stands for innovation, integrity, and impact—connecting data, technology, and expertise to improve outcomes for patients and partners worldwide. We foster a culture of collaboration, diversity, and continuous learning, empowering our teams to make a difference every day.

The Role

As a Regulatory Publishing & Submission Team Lead, you will manage a high-performing team supporting clinical trial and marketing authorization activities for both internal and external clients. You'll ensure consistent regulatory support, drive operational excellence, and champion IQVIA's commitment to quality and compliance.

Experience Required
: 12–15 years in regulatory publishing or submissions

Languages
: Professional proficiency in French and English - required; intermediate Japanese and basic Spanish - nice to have.

Key Responsibilities

  • Lead, mentor, and develop regulatory publishing staff in line with IQVIA's values and policies
  • Oversee creation, assembly, and publishing of global paper and electronic submissions (NDAs, INDs, Annual Reports, etc.)
  • Ensure compliance with regulatory processes and readiness for audits
  • Collaborate with cross-functional teams to ensure documents meet regulatory and company standards
  • Engage directly with clients, providing strategic consultancy and delivering business development presentations
  • Contribute to tool development, training, and continuous improvement initiatives
  • Maintain expertise in publishing systems (RIM Smart, Insight, eCTDXpress, Extedo, Lorenz, Veeva Vault, EMA Gateway, CESP MHRA Portal)

What We're Looking For

  • Proven leadership in regulatory publishing/submissions (12–15 years)
  • Strong technical knowledge of publishing systems and software
  • Life Science background (MSc, MPharma)
  • Excellent communication and project management skills
  • Ability to work independently and as part of a global team
  • Commitment to IQVIA's values of innovation, collaboration, and customer focus

Why IQVIA?

  • Be part of a purpose-driven organization shaping the future of healthcare
  • Work in a diverse, inclusive, and supportive environment
  • Access to cutting-edge technology and professional development opportunities
  • Competitive compensation and benefits

Ready to make an impact?
Apply now and help us deliver smarter healthcare solutions worldwide.

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

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