Regulatory Affairs Manager- Argentina

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

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

As an Affiliate Regulatory Affairs Manager, you will play a key role in leading and developing a dedicated Regulatory Affairs team while driving regulatory strategies to accelerate patient access to innovative medicinal products. Acting as a trusted partner, you will represent the company before local health authorities and ensure our regulatory filings align with both patient needs and global standards.

The Opportunity:

Plan, coordinate, and execute Regulatory Affairs processes for assigned product portfolios in compliance with local regulations and company policy. Represent the company before health authorities (e.g., ANMAT, INAME) and industry associations. Lead, mentor, and develop the assigned Regulatory Affairs team members to foster high performance, responsibility, and professional growth. Develop innovative, risk-based regulatory strategies and workplans for assigned products to accelerate patient access in alignment with global strategies. Supervise and manage regulatory filing activities, negotiating with health authorities and internal stakeholders to ensure business continuity. Provide regulatory leadership, intelligence and guidance across cross-functional affiliate teams, including Market Access, Medical Affairs, Legal, and Supply Chain. Ensure full regulatory compliance with international and local standards, leading regulatory inspection-readiness and internal/external audits. Oversee end-to-end local product packaging, labeling, and promotional material review in accordance with local regulations and industry standards.

Who you are:

You hold a University Degree in Pharmacy or a closely related healthcare scientific field. You bring proven experience in the pharmaceutical industry within similar Regulatory Affairs roles (min. 5 years). You have demonstrated experience leading, managing, and empowering teams. You possess an advanced level of English and Spanish, backed by outstanding communication and interpersonal skills. You stand out for your strong sense of responsibility, proactive attitude, and collaborative approach. You possess deep knowledge of local health authority frameworks, regulatory legislation, and international standards. You demonstrate strong strategic thinking, negotiation skills, and the ability to navigate matrixed environments. You maintain up-to-date continuous education or certifications in regulatory policy and affairs.

This position is based in Buenos Aires, reports directly to the Technical Director of Pharma Argentina, and will lead a team.

Who we are

Roche is an Equal Opportunity Employer. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.