Senior Manager, Global Regulatory Strategy

10 ore fa

firenze, toscana, Italia Angelini Pharma Tempo pieno

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

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.

Senior Manager, Global Regulatory Strategy Roma

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Senior Manager, Global Regulatory Strategy

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