Regulatory Strategist

Role Summary

Regulatory Strategist role focused on developing regulatory product strategies for Immunology and Inflammation, leading regulatory efforts in drug development. Provides regulatory expertise and guidance on procedural and documentation requirements to GRT and cross-functional teams to ensure delivery of business objectives.

Responsibilities

• Enables the GRL by providing quality regulatory input and position to internal business partners, including clinical development teams, commercial and Global Regulatory Team for assigned projects
• Liaises with clinical, commercial and other internal business partners in partnership with the GRL to enable successful regulatory outcomes
• Contributes to the development of a harmonized regulatory voice through participation in committees and forums as directed by the GRL
• Proactively contribute with curiosity and openness to diverse perspectives
• Emerging understanding of clinical development of drugs and/or novel biologics products
• Understanding of business acumen, leadership, influencing and negotiation skills
• Contribute to operational and compliance activities for assigned deliverables, including generating submission content plans, submission tracking, and document management with cross-functional input
• Effective communication skills, specifically strong oral and written presentation skills
• Ability to work in electronic document management systems (e.g., Veeva Vault, Plai) is a plus
• Demonstrated ability to handle multiple projects/deliverables simultaneously
• Strong sensitivity for a multicultural/multinational environment

Qualifications

• BS/BA in a relevant scientific discipline, or MSc in Biology, Life Science, or related field with at least 5 years of relevant pharmaceutical/biotechnology industry experience, including at least 3 years in Regulatory Affairs OR advanced degree (PharmD, PhD, MD, or DVM) with at least 2 years of regulatory or relevant industry experience

Soft Skills

• Understanding of clinical development of drugs and/or innovative biologics products
• Experience driving the preparation of regulatory documents (e.g., BLA/NDA/MAA, INDs/CTAs, health authority briefing documents) and negotiating with health authorities
• Emerging business acumen, leadership, influencing and negotiation skills
• Ability to build internal and external networks and lead discussions with stakeholders
• Strong oral and written communication skills
• Experience with electronic document management systems (e.g., Veeva Vault RIM, Plai)
• Demonstrated ability to manage multiple projects/deliverables simultaneously
• Strong sensitivity for a multicultural/multinational environment