Global Regulatory Affairs - Specialty Care


Sanofi's global specialty care business unit focuses on rare diseases, rare blood disorders, neurology, immunology, and oncology. Sanofi's ambition is to leverage science and innovation to improve people's lives and be the industry leader in immunology and oncology. Its approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. 


This fellowship is focused on providing the fellow with the necessary skills and tools to become a knowledgeable, confident and strategic Regulatory Affairs professional. The Fellow will gain hands-on experience across a variety of areas within the Global Regulatory Affairs department, developing a well-rounded understanding of the regulatory functions and drug development process from early state to post-marketing. 


  • Develop regulatory strategic skills while contributing to global pre- and post-approval planning and submissions potentially including: Briefing documents, Health Authority interactions, IND/CTA submissions, BLA/NDA/MAA applications. 
  • Lead team meetings, develop regulatory strategy, and contribute to and lead Health Authority submission with increasing responsibility throughout the Fellowship program.
  • Partner with contributing functions within Sanofi to deliver products for diseases globally.
  • Experience various facets of global Regulatory Affairs to better understand the roles of regulatory professionals.
  • Engage with global colleagues and learn country/region-specific regulatory processes.
  • Develop skills such as strategic and analytical thinking, effective communication, business acumen and partnering/collaboration. 


Become an integrated part of the GRA team through involvement in cross-functional projects with global colleagues. The Fellow will gain experience in areas of GRA such as: 

  • Global Regulatory Product Strategy 
  • Advertising and Promotion 
  • Global Labeling 
  • Regulatory CMC & Devices 
  • Regulatory Digital/Innovation 
  • Regulatory Science and Policy 
  • Others 


The Global Regulatory Affairs 

Specialty Care fellowship program will allow the individual to explore and understand the broad remit of the Regulatory Strategist (RS) role at Sanofi. 

The fellow will be following a development plan with given exposure and project driven experiences working on different therapeutic modalities at various stages of clinical development, to develop the tactical and strategic capabilities needed to be a successful regulatory professional. 


The ideal candidate for this fellowship possesses a PharmD degree and has the desire to learn the skills needed for developing regulatory strategy for products in development and preparing for FDA meetings and rehearsals. Candidates must also be motivated to collaborate with multi-disciplinary teams to meet business objectives. Candidate should be open to learning and interpreting regulations and developing an effective and strategic plan. Candidates with a passion for science, independent work ethic, interest in working collaboratively, solutions-oriented mindset, and strong time management skills are encouraged to apply. 

Location: CX only 
Preceptor: Marilyn Kiral