- Location Netherland (Amsterdam), US (Bridgewater, NJ / Cambridge, MA)
- 50% Remote working and 10% of travel expected
- Job type: Permanent, Full Time
About the job
The team is involved in developing regulatory product strategies for the Immunology and Inflammation therapeutic area, leading regulatory efforts in the development stage of drug products.
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.
- 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 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 be requested to lead Global Regulatory Team meetings
- May serve as a regional/local regulatory lead and point of contact with Health Authorities for projects/products in your remit, as needed
- Identify regulatory risks and proposes mitigations in collaboration with the GRL, to cross-functional teams working with Sanofi standardized methodologies as appropriate
- Contribute to the development of Global Regulatory Project Strategy (GRPS) and ensure alignment with the core product labeling for products in development as well as for life cycle management of products
- BS/BA degree in a relevant scientific discipline or MSc in Biology, Life Science, or related field
- At least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years of relevant Regulatory Affairs experience or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required
- 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
- Ability to work in electronic document management systems, e.g., Veeva vault is a plus
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