Global Program Regulatory & Strategy Senior Manager

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ar0z5

pulliDrive the regulatory strategy, planning and execution across key regions for the assigned development pipeline projects (from early pre-clinical phases) /liliCollaborate with cross-functional teams to ensure timely submissions, approvals, and compliance with global regulatory requirements, supporting the successful development and registration of innovative pharmaceutical products.
/li /ulh3Major Activities /h3h3Key Responsibilities /h3ulliDevelop and implement Global regulatory strategies for assigned pipeline development programs, ensuring alignment with global regulatory requirements and company objectives.
/liliProvide regulatory input into RD programs to ensure they meet regulatory expectations /liliPrepare, review, and manage regulatory submissions including INDs, NDAs, MAAs, ensuring accuracy, completeness, and timely delivery.
/liliCoordinate responses to health authority queries, ensuring scientifically sound and compliant answers within required timelines.
/liliMonitor evolving regulatory requirements across major markets (FDA, EMA, ICH,) and proactively assess their impact on development programs and submission strategies.
/liliCollaborate with cross-functional teams (RD, Clinical Development, CMC, Safety, Quality, business etc ) to ensure integrated regulatory plans /liliSupport regulatory meetings and interactions with health authorities, including briefing document preparation /liliEnsure compliance with internal SOPs and global standards, contributing to continuous improvement initiatives and best practices in regulatory operations.




/liliReview and approve Clinical Trials Applications (CTAs) /liliPerform regulatory Due Diligence activities for acquisition of new assets in development stages to enhance Company pipeline /li /ulh3Job Dimensions /h3h3Ideal Background /h3pDegree in a scientific field /ph3Languages: /h3pFluent in written and spoken English /ph3Experience/Professional requirement: /h3ulliMore than 5 years of successful managerial experience in the pharmaceutical industry with a proven track record of successful registrations of innovative products in Key Regions (i.e. EU, US, Japan) /liliStrong knowledge of regulatory submission and approval processes in Key Regions /liliStrong knowledge of Drug development regulatory processes behind with a focus on early-stage assets /liliExperience leading regulatory submissions and approvals of innovative products Key Regions /liliExperience in a global/matrix environment or cross- functional teams in the pharmaceutical industry /liliExperience on project allocation/project planning within a cross-functional team working in matrix organization /liliExcellent interpersonal, communication, negotiation and problem-solving skills.
/liliOrganizational awareness (e.g., interrelationship of departments, business priorities).
/liliFluency in English as a business language.
Excellent written and verbal communication skills.
/liliConfident, articulate, and professional speaking abilities (and experience).
Excellent presentation and negotiation skills.
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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7ar0z5