Regulatory Affairs Manager- Argentina

Roche; Municipio de Esquel; On-site; ARS 1,200,000 - 2,000,000; Full time

Job summary

Roche Argentina seeks an Affiliate Regulatory Affairs Manager to lead a dedicated Regulatory Affairs team and drive regulatory strategies to accelerate patient access to medicines. You will represent Roche before local health authorities and align filings with global standards.

Based in Buenos Aires, you will mentor the team, develop innovative strategies, supervise filings, and ensure inspection readiness while collaborating with Market Access, Legal, Medical Affairs and Supply Chain.

Qualifications

• University degree in pharmacy or closely related field.
• 5+ years in regulatory affairs in pharma.
• Strong leadership and people-management experience.

Responsibilities

• Plan, coordinate, and execute Regulatory Affairs processes for assigned products.
• Represent the company before health authorities like ANMAT and INAME.
• Lead and mentor the Regulatory Affairs team to drive performance.
• Develop risk-based regulatory strategies and work plans for products.
• Supervise and manage regulatory filing activities with authorities and internal stakeholders.
• Provide regulatory leadership and guidance across cross-functional affiliate teams.
• Ensure compliance with local and international standards; lead inspections and audits.
• Oversee local packaging, labeling, and promotional material review per regs.

Skills

Regulatory leadership

Team management

Regulatory strategy

Cross-functional collaboration

Negotiation

Education

University Degree in Pharmacy

Job description

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

A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.