Regulatory Affairs Manager – Argentina

About the role

As an Affiliate Regulatory Affairs Manager at Roche, you will lead a dedicated Regulatory Affairs team and drive strategies to accelerate patient access to innovative medicines in Argentina.

Key responsibilities

• Plan, coordinate and execute regulatory processes for assigned product portfolios in compliance with local regulations.
• Represent Roche before health authorities such as ANMAT and INAME and industry associations.
• Lead, mentor and develop the regulatory team to ensure high performance.
• Develop risk‑based regulatory strategies aligned with global objectives.
• Supervise filing activities, negotiate with authorities and ensure business continuity.
• Provide regulatory intelligence to cross‑functional teams including Market Access, Medical Affairs, Legal and Supply Chain.
• Maintain compliance with international and local standards, leading inspection‑readiness and audits.
• Oversee local product packaging, labeling and promotional material review.

Required profile

• University degree in Pharmacy or a related scientific field.
• Minimum 5 years of experience in pharmaceutical regulatory affairs.
• Proven experience leading and managing teams.
• Advanced proficiency in English and Spanish with strong communication skills.
• Deep knowledge of Argentine health authority frameworks and international regulations.
• Strategic thinking, negotiation ability and experience working in matrixed environments.

Required skills

• Regulatory filing and submission expertise.
• Knowledge of local health authority legislation (ANMAT, INAME).
• Risk‑based regulatory strategy development.