Global Program Regulatory & Strategy Senior Manager...

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7hd5ye

- Drive the regulatory strategy, planning and execution across key regions for the assigned development pipeline projects (from early pre-clinical phases) - Collaborate 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.
Major Activities Key Responsibilities - Develop and implement Global regulatory strategies for assigned pipeline development programs, ensuring alignment with global regulatory requirements and company objectives.
- Provide regulatory input into R&D; programs to ensure they meet regulatory expectations - Prepare, review, and manage regulatory submissions including INDs, NDAs, MAAs, ensuring accuracy, completeness, and timely delivery.
- Coordinate responses to health authority queries, ensuring scientifically sound and compliant answers within required timelines.
- Monitor evolving regulatory requirements across major markets (FDA, EMA, ICH,) and proactively assess their impact on development programs and submission strategies.
- Collaborate with cross-functional teams (R&D;, Clinical Development, CMC, Safety, Quality, business etc ) to ensure integrated regulatory plans - Support regulatory meetings and interactions with health authorities, including briefing document preparation - Ensure compliance with internal SOPs and global standards, contributing to continuous improvement initiatives and best practices in regulatory operations.




- Review and approve Clinical Trials Applications (CTAs) - Perform regulatory Due Diligence activities for acquisition of new assets in development stages to enhance Company pipeline Job Dimensions Ideal Background Degree in a scientific field Languages: Fluent in written and spoken English Experience/Professional requirement: - More 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) - Strong knowledge of regulatory submission and approval processes in Key Regions - Strong knowledge of Drug development & regulatory processes behind with a focus on early-stage assets - Experience leading regulatory submissions and approvals of innovative products Key Regions - Experience in a global/matrix environment or cross- functional teams in the pharmaceutical industry - Experience on project allocation/project planning within a cross-functional team working in matrix organization - Excellent interpersonal, communication, negotiation and problem-solving skills.
- Organizational awareness (e.g., interrelationship of departments, business priorities).
- Fluency in English as a business language.
Excellent written and verbal communication skills.
- Confident, 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/7hd5ye