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Regulatory Project Manager

Posted 26 Mar 2024
Work experience
5 to 7 years
Full-time / part-time
Full-time
Job function
Degree level
Required languages
English (Fluent)
Dutch (Fluent)

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About the Opportunity

The Regulatory Project Manager will be responsible for managing regulatory activities and EU strategy for products under development and/or marketed products within the Immunology and Inflammation at Global Regulatory Affairs, Region Europe (GRA-EU), including additional development and life cycle management for Dupixent (dupilumab).

About Sanofi Genzyme

Sanofi Genzyme is the specialty care global business unit of Sanofi, focused on rare diseases, multiple sclerosis, oncology, immunology and rare blood disorders. We help people with debilitating and complex conditions that are often difficult to diagnose and treat. We are dedicated to discovering and advancing new therapies, providing hope to patients and their families around the world.

Our ambition is to be the industry leader in specialty care. We currently provide more than 20 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.

Key responsibilities

  • Develop EU regulatory strategy and provide regulatory expertise within project teams for the additional development and life cycle management of dupilumab;
  • Coordinate the preparation and contribute to writing and review of regulatory documentation in collaboration with key internal stakeholders (nonclinical, clinical, medical, pharmacovigilance functions, etc.):
  • Documentation may entail CTAs, paediatric investigation plan, and major regulatory submissions (e.g. MAA) and any type of response-documents to Health Authority questions.
  • Ensure maintenance and compliance of regulatory activities (like DSURs, PSURs; PIP annual update), including archiving and tracking in databases and systems, and support inspection readiness;
  • Coordinate Regulatory sub-teams for planning and strategy of European Submissions and be the EU regulatory representative for alignment in GRA and multi-functional teams (Regional):
  • Review and contribute to development plans for the assigned product(s) from a regional regulatory perspective;
  • Develop and execute Region Europe agency relations management strategy.
  • Lead and coordinate scientific advice requests (including briefing package preparation), oral explanations and pre-submission meetings for development and Lifecycle management projects;
  • Follow regulatory intelligence updates and competitor’s status and assess potential impact on daily activities and project strategy, including sharing with the appropriate stakeholders within the department or project team(s).

About you

  • Master’s degree in a Life Sciences subject, e.g. Physician, Pharmacist, Veterinarian or other Life Sciences Degree;
  • Minimum of 5 years of relevant work experience in EU Regulatory Affairs, or in a business with close relationship with Regulatory affairs function;
  • Comprehensive knowledge and operational expertise of EU regulations, and ability to implement this into regulatory strategy and practice;
  • Development skills;
  • Excellent scientific writing and presentation skills;
  • Experience in the field of biologicals / rare diseases;
  • Ability to produce written and oral regulatory or scientific communications with clarity and accuracy;
  • Good planning, project, process, and people management skills;
  • Ability to lead and organize regulatory deliverables in a matrix environment;
  • Ability and flexibility to work with multifunctional and multicultural teams with strong understanding of organizational and inter-cultural sensitivities;
  • Good negotiating skills;
  • Ability to communicate effectively and efficiently with other functions in the business, as well as with the Health Authorities;
  • Result driven with a sense of responsibility and urgency and able to perform and multi-task under pressure;
  • Ability to resolve complex issues with proactivity and independent working attitude depending on stakeholders’ needs;
  • Fluent English in writing and verbally;
  • Affinity for systems and technology.

What Sanofi can offer you

  • A generous package including flexible benefits;
  • A healthy work-life balance throughout your career with us.

About Sanofi

Empower Life Everyday

At Sanofi we work across human health from vaccines to rare diseases, and consumer healthcare. This creates opportunities to work across different areas to build a diverse and exciting career. Sanofi has the capabilities and resources to support your aspirations to fulfill your ambitions and be the best you can be.

Our purpose at Sanofi is to work passionately every day to understand and solve healthcare needs of people across the world. Our ambition is by 2025, to be a top 3 innovative, global and diversified human healthcare company. One that embraces transformative technologies and is focused on its area of excellence, which means we’re not there to try to solve everybody’s problems. We want to focus on those areas where we know we are making a difference.

The values we live by are teamwork, courage, respect and integrity.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.

Sanofi is a global life sciences company committed to improving access to healthcare and supporting the people we serve throughout the continuum of care. From prevention to treatment, Sanofi transforms scientific innovation into healthcare solutions.

Pharmaceutical
Amsterdam
100,000 employees