We're thrilled to announce an exclusive opportunity for a regulatory affairs associate director with a renowned global pharmaceutical company.
this strategic role, based in madrid, spain, offers a unique chance to shape and implement groundbreaking regulatory strategies on a global scale, directly aligning with the company's overall business objectives.
role overview:
as the regulatory affairs associate director, your primary mission will be to develop and execute innovative global regulatory strategies that drive product development and approval across international markets.
this role requires a deep understanding of complex regulatory landscapes and the ability to collaborate effectively with major health authorities (us, eu, japan, and china) to ensure successful compliance and approval.
key responsibilities:
strategic leadership: spearhead the development and execution of integrated global regulatory strategies for assigned projects and products.
global representation:act as the company's regulatory representative in communications with regulatory authorities, contractors, and corporate partners.
clinical & pre-clinical guidance: oversee regulatory strategies related to clinical and pre-clinical product phases, supporting lifecycle management and clinical development planning.
risk mitigation: assess and mitigate regulatory risks, providing crucial guidance to internal teams throughout the r&d process.
número de vacantes: 1
modalidad de trabajo: presencial
tipo de contrato: indefinido
*ventajas sociales o económicas*
cross-functional collaboration: advise and collaborate with cross-functional teams on global regulatory requirements, ensuring alignment with strategic objectives.
regulatory insights: monitor and analyze regulatory agency activities, assess their impact on ongoing programs, and provide timely strategic advice.
mentorship & development:mentor and guide regulatory project managers and foster their development within the organization.
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*requisitos*
qualifications:
degree in life sciences or a related field is required; an advanced degree (pharmd, msc, phd, mba) is preferred.
*experience*:
industry expertise:minimum of 8 years in the pharmaceutical or biotechnology industry, with at least 6 years in regulatory affairs (strategy).
global regulatory knowledge: in-depth understanding of regulatory landscapes in the us, eu, and japan, with direct experience engaging with regulatory bodies such as fda, ema, and pmda.
submission experience: proven track record of preparing and managing major regulatory submissions and amendments.
cross-cultural sensitivity: experience in multinational settings and leading multidisciplinary teams.
key skills:
leadership & communication: exceptional leadership abilities, with strong interpersonal skills for effective collaboration across senior management, scientific, and manufacturing teams.
organizational excellence: strong organizational skills to prioritize workloads effectively in a dynamic environment.
strategic vision:ability to set direction, influence decision-making, and represent the company in high-stakes regulatory discussions.
if you're ready to take on a pivotal role that will shape the future of global regulatory strategy within a highly respected pharmaceutical organization, we invite you to apply.
this is an extraordinary opportunity to lead, innovate, and make a lasting impact on the global healthcare landscape.
en ciencias de la salud
estudios mínimos
licenciado
*idiomas*:
inglés nível alto.
experiência mínima
de 5 a 10 años
disponibilidad para viajar
ninguna