Senior Manager, Global Regulatory Strategy

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/83lgxc

Drive the regulatory strategy, planning and execution across key regions for the assigned development pipeline projects (from early preclinical phases)

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- 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

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. xysqume We are committed to create and foster a diverse and inclusive environment.

Senior Manager, Global Regulatory Strategy Roma

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Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/83lgxc