Senior Manager, Global Regulatory Strategy

• 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.