Sanofi

Global Regulatory Strategist

Sanofi

Amsterdam, Netherlands
Full-TimeDepends on ExperienceSenior LevelMasters
Job Description

Welcome to Sanofi, a leading global pharmaceutical company dedicated to improving the lives of patients around the world. We are currently seeking a highly skilled and motivated Global Regulatory Strategist to join our team. As a Global Regulatory Strategist, you will play a key role in ensuring compliance with various regulatory requirements and contributing to the successful registration and marketing of our products. This is a unique opportunity to make a significant impact and drive positive change in a dynamic and innovative environment. We are looking for a candidate with a strong regulatory background, excellent communication and leadership skills, and a passion for making a difference in the healthcare industry. If you are a driven and strategic thinker with a desire to work on a global scale, we would love to hear from you. Join us and be a part of our mission to improve the lives of patients worldwide.

  1. Develop and implement global regulatory strategies to ensure timely and successful registration and marketing of our pharmaceutical products.
  2. Stay up-to-date on global regulatory requirements and changes in the pharmaceutical industry, and communicate these updates to relevant stakeholders.
  3. Collaborate with cross-functional teams, including R&D, Quality, and Commercial, to ensure compliance with regulatory standards and guidelines.
  4. Lead and coordinate the preparation and submission of regulatory documents to global health authorities.
  5. Act as the primary point of contact for health authorities and represent the company in regulatory meetings and interactions.
  6. Provide strategic regulatory guidance and support to internal teams, including reviewing and approving labeling, promotional materials, and clinical trial protocols.
  7. Monitor and anticipate potential regulatory issues and provide recommendations to mitigate risks.
  8. Conduct regulatory impact assessments for new product development and changes to existing products.
  9. Mentor and train junior regulatory team members on global regulatory requirements and processes.
  10. Participate in regulatory intelligence gathering and analysis to inform decision making and strategic planning.
  11. Develop and maintain strong relationships with regulatory agencies and industry associations.
  12. Drive continuous improvement and ensure adherence to company policies and procedures.
  13. Represent the company in industry conferences and events to enhance our reputation and brand.
  14. Collaborate with global affiliates to ensure consistency and alignment in regulatory strategies and submissions.
  15. Contribute to the development and maintenance of regulatory processes and standard operating procedures.
Where is this job?
This job is located at Amsterdam, Netherlands
Job Qualifications
  • In-Depth Knowledge Of Global Regulatory Requirements: A Global Regulatory Strategist At Sanofi Should Possess A Comprehensive Understanding Of The Regulatory Landscape In Major Global Markets, Including The United States, Europe, And Emerging Markets. This Includes Knowledge Of Regulatory Agencies, Submission Requirements, And Approval Processes.

  • Strong Communication And Negotiation Skills: As A Global Regulatory Strategist, You Will Be Responsible For Communicating With Regulatory Authorities And Representing Sanofi's Interests In Regulatory Discussions. Therefore, Strong Communication And Negotiation Skills Are Essential To Effectively Navigate The Complex Regulatory Environment And Achieve Favorable Outcomes.

  • Experience With Regulatory Submissions: This Role Requires Experience With Preparing And Submitting Regulatory Applications, Including Inds, Ndas, And Maas. A Successful Global Regulatory Strategist At Sanofi Should Have A Track Record Of Submitting High-Quality, Successful Regulatory Applications.

  • Scientific Expertise: A Strong Scientific Background Is Essential For Understanding And Interpreting Complex Scientific Data And Effectively Communicating It To Regulatory Agencies. A Global Regulatory Strategist Should Have A Degree In A Scientific Discipline, Such As Biology, Chemistry, Or Pharmacy, And Experience Working In A Scientific Or Clinical Research Environment.

  • Knowledge Of Drug Development Process: A Global Regulatory Strategist Should Have A Thorough Understanding Of The Drug Development Process, From Pre-Clinical Studies To Post-Marketing Activities. This Includes Knowledge Of Clinical Trial Design, Data Analysis, And Risk Management, As Well As The Ability To Identify Potential Regulatory Roadblocks And Develop Strategies To Overcome Them.

Required Skills
  • Drug development

  • Risk assessment

  • Regulatory compliance

  • Regulatory Affairs

  • Clinical Trials

  • Product Registration

  • Regulatory Strategy

  • Pharmacovigilance

  • Pharmaceutical Industry

  • International Regulations

  • Labeling Requirements

Soft Skills
  • Communication

  • Conflict Resolution

  • Emotional Intelligence

  • Leadership

  • Time management

  • Interpersonal Skills

  • Critical thinking

  • Teamwork

  • Adaptability

  • Problem-Solving

Compensation

According to JobzMall, the average salary range for a Global Regulatory Strategist in Amsterdam, Netherlands is approximately €74,000 to €98,000 per year. This may vary depending on the specific company, experience level, and industry. Some companies may offer additional benefits such as bonuses, stock options, and relocation assistance.

Additional Information
Sanofi is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Required LanguagesDutch
Job PostedMarch 21st, 2025
Apply BeforeNovember 16th, 2025
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About Sanofi

Sanofi SA is a French multinational pharmaceutical company headquartered in Paris, France, the world's fifth-largest by prescription sales. Building a More Equitable Future through Inclusive Clinical Trials · Rethinking the science of COPD · Grassroots Manufacturing Solutions for a Healthier Planet.

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