Regulatory Affairs Project Manager

hace 1 semana


Madrid, España Jr Spain A tiempo completo

col-wideJob Description:We are looking for Regulatory Affairs Project Manager to join an innovative pharma company to lead the regulatory strategy of drug development.Reporting directly to the Regulatory Affairs Associate Director, you will be responsible:Managing the Regulatory aspects related to the development, registration and licence maintenance of one or more R-D projects.::Contribute to the preparation and maintenance of labeling (i.e:labels, leaflets, SmPCs, USPI, etc).:Collaborate in the preparation of responses to regulatory queries (CTAs, labeling, INDs, MAAs).::Participate in international project development teams.:Prepare and review SOPs.:Assist in the design of international regulatory strategies for allocated products.:Work closely and supervises CRO.:Work and collaborate effectively with business partnersWhat are we looking forWe are looking for a professional with:A high University Degree in Health Sciences preferably with a PhD, MSc or MBA:Aproficient level of English language and thus fluent in spoken and written English:Excellent interpersonal, team work and project management skills:Demonstrated good communication and negotiation skillsIf yourare interested please do not hesitate to get in touch for more information.We are looking forward to hear from you



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