Global Regulatory Strategy Lead – Pharma Development

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

Descrizione del lavoro

Angelini Pharma in Rome seeks a seasoned Regulatory Affairs leader to drive global regulatory strategies across development programs. You will coordinate cross-functional teams, support submissions, and manage health authority interactions to advance innovative products.

The ideal candidate brings 5+ years of managerial pharma-regulatory experience, strong global submission expertise, and excellent communication skills in English.

Competenze

• More than 5 years of managerial experience in the pharmaceutical industry.
• Strong knowledge of regulatory submission and approval processes in key regions.
• Experience leading regulatory submissions for innovative products.
• Excellent interpersonal, communication, negotiation and problem-solving skills.

Mansioni

• Develop and implement Global regulatory strategies for assigned pipeline development programs.
• Provide regulatory input into R&D programs to ensure regulatory expectations are met.
• Prepare, review, and manage regulatory submissions including INDs, NDAs, MAAs.
• Coordinate responses to health authority queries with scientifically sound, timely answers.
• Monitor evolving regulatory requirements across major markets (FDA, EMA, ICH) and assess impact.
• Collaborate with cross-functional teams to ensure integrated regulatory plans.
• Support regulatory meetings and briefing document preparation with health authorities.
• Ensure compliance with internal SOPs and global standards in regulatory operations.

Conoscenze

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Project management

English proficiency

Formazione

Degree in science

Descrizione del lavoro

Angelini Pharma in Rome seeks a seasoned Regulatory Affairs leader to drive global regulatory strategies across development programs. You will coordinate cross-functional teams, support submissions, and manage health authority interactions to advance innovative products.

The ideal candidate brings 5+ years of managerial pharma-regulatory experience, strong global submission expertise, and excellent communication skills in English.