Role Summary
Regulatory Strategist collaborates with the Global Regulatory Team to define and drive the global regulatory strategy for assigned projects, including US, EU, and/or global regulatory activities and Health Authority interactions. The role provides regulatory guidance on procedural and documentation requirements to cross-functional teams, ensuring alignment with business objectives and timely delivery. Responsibilities
Enables the Global Regulatory Lead by providing quality regulatory input and position to internal partners, including clinical development teams, commercial, and GRT for assigned projects. Contributes to the Global Regulatory Team’s input on Target Product Profile, business planning, governance, and committees; may lead GRT meetings. Contributes to the Global Regulatory Project Strategy and ensures alignment with core product labeling for development and lifecycle management. May serve as regional/local regulatory lead and point of contact with health authorities for projects in their remit, as needed. Develops HA engagement and interaction plans, including authoring briefing documents, guiding meeting preparations, and moderating meetings for projects in their remit. May lead HA meetings and preparations; leads submission teams to ensure NDA/BLA/MAA/Extensions filings meet timelines for product launch and develops/updates the core global dossier (collaborates with regional leads for region-specific submissions). Leads IND/CTA submission strategy to meet timelines for clinical trial initiation. Supports operational and compliance activities for assigned deliverables; develops and executes regulatory submission planning, including submission content plans, tracking, and document management with cross-functional or alliance partner input. Qualifications
Required: BS/BA degree in a relevant scientific discipline. Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field). Required: At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of regulatory affairs experience (regional and global) in early and late-stage development across multiple modalities. Preferred: Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents, and negotiation with a national/regional HA. Preferred: Experience on multidisciplinary matrixed project teams (e.g., clinical study teams). Preferred: Project leadership experience.
#J-18808-Ljbffr
Regulatory Strategist collaborates with the Global Regulatory Team to define and drive the global regulatory strategy for assigned projects, including US, EU, and/or global regulatory activities and Health Authority interactions. The role provides regulatory guidance on procedural and documentation requirements to cross-functional teams, ensuring alignment with business objectives and timely delivery. Responsibilities
Enables the Global Regulatory Lead by providing quality regulatory input and position to internal partners, including clinical development teams, commercial, and GRT for assigned projects. Contributes to the Global Regulatory Team’s input on Target Product Profile, business planning, governance, and committees; may lead GRT meetings. Contributes to the Global Regulatory Project Strategy and ensures alignment with core product labeling for development and lifecycle management. May serve as regional/local regulatory lead and point of contact with health authorities for projects in their remit, as needed. Develops HA engagement and interaction plans, including authoring briefing documents, guiding meeting preparations, and moderating meetings for projects in their remit. May lead HA meetings and preparations; leads submission teams to ensure NDA/BLA/MAA/Extensions filings meet timelines for product launch and develops/updates the core global dossier (collaborates with regional leads for region-specific submissions). Leads IND/CTA submission strategy to meet timelines for clinical trial initiation. Supports operational and compliance activities for assigned deliverables; develops and executes regulatory submission planning, including submission content plans, tracking, and document management with cross-functional or alliance partner input. Qualifications
Required: BS/BA degree in a relevant scientific discipline. Preferred: Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology, Life Science, or related field). Required: At least 6 years of relevant pharmaceutical/biotechnology experience, including at least 4 years of regulatory affairs experience (regional and global) in early and late-stage development across multiple modalities. Preferred: Demonstrated experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs, HA briefing documents, and negotiation with a national/regional HA. Preferred: Experience on multidisciplinary matrixed project teams (e.g., clinical study teams). Preferred: Project leadership experience.
#J-18808-Ljbffr