Senior Global Regulatory Strategy Manager

Angelini Pharma; Roma; In loco; EUR 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

Angelini Pharma is seeking an experienced regulatory affairs leader to drive global regulatory strategies for development programs. The role requires coordinating cross-functional teams, ensuring timely IND/ NDA/ MAA submissions, and responding to health authority queries with scientifically sound arguments.

Ideal candidates will have 5+ years of managerial pharma experience, strong knowledge of EU/US/Japan processes, and a proven track record in major market registrations.

Competenze

• More than 5 years managerial experience in the pharmaceutical industry with registrations in EU, US, Japan.
• Strong knowledge of regulatory submission and approval processes in Key Regions.
• Experience leading regulatory submissions and approvals for innovative products in Key Regions.
• Experience in a global/matrix environment or cross-functional teams in the pharmaceutical industry.

Mansioni

• 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 with scientifically sound and compliant answers within timelines.
• Monitor evolving regulatory requirements across major markets (FDA, EMA, ICH) and assess impact on development programs and submission strategies.
• Collaborate with cross-functional teams to ensure integrated regulatory plans.
• Support regulatory meetings and briefing document preparation.
• Ensure compliance with internal SOPs and global standards, contributing to continuous improvement in regulatory operations.
• Review and approve Clinical Trials Applications (CTAs).
• Perform regulatory Due Diligence activities for acquisitions of new assets in development stages to enhance the Company pipeline.

Conoscenze

Regulatory strategy

Cross-functional collaboration

Regulatory submissions

Project management

Communication skills

English fluency

Formazione

Scientific degree

Descrizione del lavoro

Angelini Pharma is seeking an experienced regulatory affairs leader to drive global regulatory strategies for development programs. The role requires coordinating cross-functional teams, ensuring timely IND/ NDA/ MAA submissions, and responding to health authority queries with scientifically sound arguments.

Ideal candidates will have 5+ years of managerial pharma experience, strong knowledge of EU/US/Japan processes, and a proven track record in major market registrations.