Regulatory Strategist

Role Summary

The Regulatory Strategist develops and drives global regulatory strategy for assigned projects, enabling execution of aligned US, EU, and global regulatory plans and Health Authority interactions. S/he provides regulatory expertise to the Global Regulatory Team and cross-functional partners to ensure delivery of business objectives.

Responsibilities

• Enable the Global Regulatory Lead by providing high-quality regulatory input and positioning to internal partners, including clinical development, commercial, and the Global Regulatory Team for assigned projects.
• Contribute to the Global Regulatory Team’s input on the Target Product Profile, business planning, governance, and committees, with potential to lead GRT meetings.
• Support development of the Global Regulatory Project Strategy and ensure alignment with core product labeling for development and lifecycle management.
• Serve as regional/local regulatory lead and point of contact with Health Authorities as needed.
• Develop HA engagement and interaction plans for assigned products, including authoring briefing documents, leading meeting preparations, and moderating meetings.
• Lead HA meetings and preparations as designated.
• Lead submission teams to ensure NDA/BLA/MAA/Extensions filings meet project timelines for product launch; develop and update the core global dossier and collaborate with regional leads for region-specific submissions.
• Lead IND/CTA submission strategy to meet timelines for clinical trial initiation.
• Support operational and compliance activities for assigned deliverables, including regulatory submission planning, content plans, submission tracking, and document management with cross-functional and alliance partners as relevant.

Qualifications

About You

• Required: BS/BA in a relevant scientific discipline. Advanced degree (PharmD, PhD, MD, DVM, or MSc in Biology/Life Science or related field) preferred.
• Required: At least 6 years of pharmaceutical/biotechnology experience, including at least 4 years in Regulatory Affairs (regional and global) across early and late-stage development of multiple modalities.
• Required: Experience with preparation of submission documents (sBLA/sNDA/MAA), INDs/CTAs, HA briefing documents, and negotiation with national/regional HAs.
• Preferred: Experience on multidisciplinary matrixed project teams (e.g., clinical study teams).
• Preferred: Project leadership experience.