Regulatory Strategist - VIE Contract

Regulatory Strategist - VIE Contract

• Location: United States of America, Morristown
• Target start date: 01/09/2025

iMove, the Sanofi VIE Program, is available to citizens of the European Economic Area (EU + Norway, Liechtenstein and Iceland) aged between 18 and 28.

PLEASE NOTE that since this program is primarily an international development program, candidates cannot apply to a VIE assignment in their own country of citizenship.

PLEASE NOTE that applications that are only submitted in French cannot be considered by our non-French speaking partners at Sanofi worldwide. Therefore, only applications that are submitted in English will be considered. Please make sure to apply with your personal email address.

About the job

Looking to launch your career at the cutting edge of healthcare? Join Sanofi for a chance to develop with mentoring and guidance from inspirational leaders while helping to make an impact on the lives of countless people worldwide. As Regulatory Strategist VIE in our Regulatory Affairs team you will contribute to the creation of regulatory strategies, in collaboration with global stakeholders.

We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.

Main responsibilities:

• Contribute to the creation of the regulatory strategy, in collaboration with global stakeholders, regional leads and local teams, on various projects.
• Partner with cross-functional team members (Medical, PV, Business, Industrial Affairs, Legal and other Global Regulatory Affairs functions) and provide regulatory leadership as applicable in order to develop global regulatory strategies, including strategies for Product Alert Teams/Crisis teams, as appropriate.
• Assist in the preparation of the registration strategy and its execution for various regulatory procedures (responses to Health Authorities questions, labeling changes, risk minimization measures).
• Maintain compliance with all internal and external requirements and procedures and execute the maintenance activities in due time (e.g. contribution to PBRER).
• Research and analyze regulatory information and maintain current regulatory knowledge to keep abreast of regulatory procedures and changes, including their impact.
• Update specific record tracking databases (Veeva Vault).
• Suggest improvements to operating policies/processes, as appropriate.

About you

Experience:

• 1+ year of experience in Regulatory Affairs in the Pharmaceutical industries.
• Experience in Global Regulatory Affairs, in international environment or in project management is a plus.
  

Soft and Technical skills:

• You are rigorous and known for your analytical and synthesis skills.
• You are motivated and open-minded, you like working in a team and interacting on cross-cutting and multicultural subjects.
• You have a solid knowledge and understanding of complex medical and scientific subject matter as well as evolving regulatory policy.
• You have a strong appetite to novel methodologies for regulatory decision making (Real-world evidence, patient focused drug development).
• You have a good understanding of the Global Regulatory environment and requirements (including Canada, US, EU, WHO, China, Japan in particular) and pharmaceutical marketplace.
• You have an unquestionable ethics, professional integrity, and personal values consistent with the Sanofi values.
• Proficient in the use of Microsoft Word, PowerPoint, Excel.
• Proficient in the use of collaborative work environment tools (eg. SharePoint, Teams).

Education:

• Master’s degree in Pharmacy, Life Science or other related field.
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Languages:

• Fluent English (written and verbal).
• French would be an asset.