Regulatory Strategy Lead

Job Title: Regulatory Strategy Lead

Job Location: Oeiras, Portugal

Job Location Type: Home-based

Job Contract Type: Full time
Job Seniority Level:
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 regulator