Regulatory Strategy Lead

Job Overview

The Director, Regulatory Affairs provides senior regulatory and integrated project leadership for global drug development projects, with deep hands‑on expertise in US and EU regulatory strategy and delivery. The role acts as both Regulatory Lead and Project Lead, with direct accountability for authoring and delivering key regulatory submissions and leading cross‑functional development activities, including Indication Prioritization assessment, Target Product Profiles (TPP), and Clinical Development Plans (CDP). Working directly with biopharmaceutical clients, this role serves as a trusted strategic advisor and primary point of contact, integrating regulatory, clinical, safety, CMC, nonclinical, biostatistical, and commercial inputs to drive high‑quality, compliant, and executable development strategies across the product lifecycle, delivered on time, within scope, and within budget.

Essential Functions

• Acts as Project Lead for development projects that combine regulatory deliverables and cross‑functional development strategy, including Indication Prioritization, Target Product Profile (TPP) development, and Clinical Development Plans (CDP).
• Provides end‑to‑end project leadership, integrating regulatory strategy with clinical, nonclinical, CMC, biostatistics, and commercial considerations to deliver coherent, executable development plans across the drug development lifecycle.
• Serves as Regulatory Lead for assigned projects, with direct accountability for the strategy, authoring, review, and delivery of key regulatory documents, including US INDs, NDA/BLA,  EMA/UK CTA/MAA‑related deliverables, agency interactions, and lifecycle regulatory submissions.
• Leads and authors core regulatory strategy documents, ensuring alignment between regulatory pathways and broader development objectives, and translating regulatory requirements into actionable development plans.
• Development of special designations (orphan drugs, pediatrics plans, “fast-track”, “break-through” etc)
• Acts as the primary client point of contact, providing strategic leadership, clear communication, and trusted advisory support across both regulatory and development strategy topics.
• Leads cross‑functional matrix teams without direct line authority, aligning functional inputs, driving timely decision‑making, and maintaining focus on project objectives, risks, and priorities.
• Owns project‑level planning and execution, including scope definition, integrated timelines, risk identification and mitigation, dependency management, and delivery of agreed milestones.
• Accountable for project budgets and resourcing, working closely with functional leaders and finance to ensure efficient utilization of resources and transparent financial management.
• Leads preparation for and facilitation of governance forums, internal reviews, and client decision meetings, synthesizing complex regulatory and development information into clear options and recommendations.
• Anticipates regulatory and development risks across US and EU projects, proactively developing mitigation strategies and advising clients on regulatory and development trade‑offs and contingencies.
• Contributes to business development activities, including authoring and defending integrated regulatory and development proposals, estimates, and timelines to clients.
• Mentors junior colleagues and Project Leads, role‑modelling integrated project leadership and high‑quality regulatory and development deliverable standards.

Qualifications

• Master’s degree in Life Sciences or a related discipline, or equivalent combination of education, training, and experience.
• Minimum of 8 years of relevant experience, including significant hands‑on regulatory experience across both the US and EU/UK, with increasing responsibility for regulatory strategy and delivery.
• Demonstrated experience leading and authoring major regulatory deliverables, including US INDs and associated FDA interactions, and contributing to and/or leading EU/UK regulatory procedures such as CTAs, scientific advice, MAA‑related activities.
• Proven ability to develop and drive regulatory strategy across the drug development lifecycle, from early development through registration, ensuring alignment with overall development and commercial objectives.
• Experience working within global, cross‑functional development teams, contributing regulatory leadership to integrated development plans, including Indication Prioritization assessments, Target Product Profiles (TPP), and Clinical Development Plans (CDP).
• Demonstrated experience acting as a cross‑functional Project Lead.
• Strong capability to lead matrixed, multidisciplinary teams (e.g., clinical, CMC, nonclinical, biostatistics, clinical pharmacology) without direct line authority, while maintaining accountability for integrated project outcomes.
• Experience managing complex timelines, risks, budgets, and resourcing across multiple functions and, where applicable, regions.
• Ability to translate complex regulatory requirements into clear, actionable development strategies, and to guide teams and clients through regulatory and development trade‑offs.
• Strong client‑facing skills, with experience acting as a trusted regulatory and development advisor, including leading client meetings, regulatory interactions, and governance discussions.
• Advanced written and verbal communication skills, with a demonstrated ability to write high‑quality regulatory and strategic documents and present clear recommendations to senior stakeholders.
• Demonstrated judgment, resilience, and flexibility when operating in ambiguous or high‑pressure environments, including the ability to proactively identify issues and drive solutions.
• Commitment to quality and compliance

IQVIA is a leading global provider of clinical research services, commercial insights, and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at https://jobs.iqvia.com.

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