Regulatory Strategy Lead
On-siteOeiras, Lisbon, Portugal
Oeiras, Lisbon, PortugalOn-siteFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Lead regulatory strategy and project delivery for global drug development, authoring key submissions including US INDs and EMA/UK CTA/MAA deliverables. Manage end-to-end project leadership for Indication Prioritization, Target Product Profiles, and Clinical Development Plans, integrating clinical, safety, CMC, and commercial inputs. Serve as the primary client advisor, facilitating governance forums, managing budgets, and anticipating regulatory risks across US and EU projects. Mentor junior colleagues and drive cross-functional matrix teams without direct line authority to ensure on-time, compliant execution.
Required 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
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.