Sanofi: Global Regulatory Affairs – Labeling
Overview:
The GRA 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, developing a well-rounded understanding of the regulatory functions and drug development process from early stage to post-marketing, including how technology, especially artificial intelligence, can be leveraged to enhance our ways of working.
Goal:
The GRA 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 have a well-rounded understanding of the regulatory functions and drug development process from the early stage to post-marketing and life cycle, including how technology, especially artificial intelligence, can be leveraged to enhance our ways of working.
Objectives:
- Develop necessary skills for authoring and facilitating the development of corporate, US, and EU labeling for products in development and marketed products in various Sanofi’s portfolio.
- Gain knowledge and understanding of the drug development process and the role of labeling in the lifecycle of a product.
- Become knowledgeable of current FDA, EMA, and other health authority regulations, guidance, and current industry standards impacting product labeling and beyond.
- Develop the skills necessary to lead cross-functional matrix teams to deliver optimal label content (Labeling Working Group) and gain approval through governance processes.
- Understand the importance of labeling strategy related to the development and negotiation of labeling for investigational compounds and marketed products with health authorities.
- Support local affiliates with the implementation of core labeling information into local labels.
- Develop submission-ready labeling documents which are in line with applicable laws, regulations, and guidance.
Sanofi Component:
The fellow will be following a development plan with given exposure and project-driven experiences to develop the tactical and strategic capabilities needed to be a successful regulatory professional. Ultimately become an integrated part of the GRA team through involvement in cross-functional projects with global colleagues.
Ideal Candidate:
- PharmD
- Desire to learn the skills needed for developing regulatory strategy for products in both the pre-approval and post-approval setting
- Be motivated to collaborate with multidisciplinary teams to meet business objectives
- Be open to learning and interpreting regulations and applying them to develop a labeling strategy and implement it within a larger regulatory strategic plan
- Candidates with a passion for science, independent work ethic, collaborative spirit, solutions-oriented mindset, and strong time management skills are encouraged to apply