Regulatory Strategist

About the job

Our Team:

The team is involved in developing regulatory product strategies for the Rare Disease & Rare Blood Disorders therapeutic area, leading regulatory efforts in the development stage and post-marketing of drug products.

Main responsibilities:

As a key member of the Global Regulatory Team (GRT), and strategic partner to the Global Regulatory Lead (GRL), you will leverage your regulatory expertise to contribute to the definition of the global regulatory strategy, to enable and drive the execution of aligned US, EU and/or global regulatory strategy for assigned projects, including Health Authority interactions.

• Management and conduct of the global regulatory activities for assigned projects in line with regulatory requirements. Provide operational support as needed on development and marketed products. Preparing, compiling, reviewing and processing the regulatory submissions for both pre-approval and registration maintenance activities such as IND, CTA, scientific advice, paediatric investigation plans, NDA/BLA/MAA, amendments/supplements and variations, response documents, annual reports, study protocols, study reports, investigator brochures, safety reports, etc.
• Supports operational and compliance activities for assigned deliverables, develops, executes regulatory submission planning activities, including generating submission content plans, submission tracking, and document management.
• You will provide regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
• Enable the GRL by providing quality regulatory input and position to internal business partners, including, but not limited to, the clinical development teams, commercial and Global Regulatory Team for assigned projects
• Liaise with clinical, commercial, and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contribute to the development of a harmonized, One Sanofi regulatory voice through participation in appropriate committees, forums at the direction of the GRL
• Contribute to the GRT for assigned projects in alignment with the team’s one regulatory voice for providing strategic input on the TPP, business planning, governance, and committees.
• May serve as a regional/local regulatory lead and point of contact with Health Authorities for

projects/products in their remit, as needed

• May lead Health Authority meetings and preparations as designated
• Leads the IND/ CTA submission strategy to ensure preparation timelines meet the project timelines

for clinical trial initiation

About you

• Education and Experience:
  • BS/BA degree in a relevant scientific discipline MSc in Biology, Life Science, or related field with at least 4 years of prior pharmaceutical/biotechnology industry experience, including at least 2 years of relevant Regulatory Affairs experience (regionally and/or global) either in post-marketing or in development phase
  • Advanced degree (PharmD, PhD, MD or DVM) with 2 years of relevant Regulatory Affairs experience (regionally and/or global) either in post-marketing or in development phase required.
• Soft skills:
  • Proactively contribute with curiosity and openness to diverse perspectives
  • Emerging understanding of clinical development of drugs and/or novel biologics products
  • Demonstrate business acumen, leadership, influencing and negotiation skills
  • Effective communication skills, specifically strong oral and written presentation skills preferred
  • Demonstrated ability to handle multiple projects/deliverables simultaneously is preferred
  • Strong sensitivity for a multicultural/multinational environment.
• Technical skills:
  • Ability to work in electronic document management systems, e.g., Veeva Vault is a plus

#LI-EUR #LI-Hybrid