Senior Manager, Global Regulatory Strategy

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

Questa posizione è in Angelini Pharma

Il processo di selezione sarà interamente gestito Angelini Pharma.

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- 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. **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 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. The salary for this role starts from 64.000€ gross per year, depending on experience and location. The offer is determined based on gender-neutral criteria, including relevant skills, competencies, and experience. **Angelini Pharma is an Equal Opportunity Employer.** We believe that diversity is a huge value that contributes to individual and company success. We are committed to create and foster a diverse and inclusive environment.

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