Argentina Regulatory Affairs Manager — Lead & Accelerate

F. Hoffmann-La Roche AG; Buenos Aires; Presencial; ARS 2.400.000 - 4.200.000; Jornada completa

Descripción de la vacante

Roche is seeking an Affiliate Regulatory Affairs Manager in Buenos Aires to lead a dedicated regulatory team and drive strategic regulatory plans. You will ensure filings align with local requirements and global standards, while accelerating patient access to innovative medicines.

You will act as a liaison with health authorities, mentor staff, and collaborate with cross-functional teams including Market Access, Medical Affairs and Legal to ensure compliant, timely submissions.

Formación

• Pharmacy degree required and relevant regulatory experience in pharma.
• Minimum 5 years in Regulatory Affairs with leadership experience.
• Advanced English and Spanish with strong communication skills.

Responsabilidades

• Plan, coordinate and execute regulatory processes for product portfolios.
• Represent Roche before local health authorities (ANMAT, INAME) and associations.
• Lead and develop the regulatory affairs team and align with global strategies.

Conocimientos

Regulatory affairs

Team leadership

Stakeholder management

Negotiation

Communication

English

Spanish

Educación

Pharmacy degree

Descripción del empleo

Roche is seeking an Affiliate Regulatory Affairs Manager in Buenos Aires to lead a dedicated regulatory team and drive strategic regulatory plans. You will ensure filings align with local requirements and global standards, while accelerating patient access to innovative medicines.

You will act as a liaison with health authorities, mentor staff, and collaborate with cross-functional teams including Market Access, Medical Affairs and Legal to ensure compliant, timely submissions.