Diretores de Estratégia e Planeamento (M/F)

Mestrado

Não

Sim

96 meses

Sim

Não

Only application in English. Masters 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 and 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 leading EU and 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 and clinical development plans. 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.

Sem termo

A tempo completo

Diurno

7.5

Teletrabalho

88200 EUR/Ano

Subsídio de alimentação
8 EUR / dia

A entidade contratante declara não possuir IRCT.