Regulatory Affairs Manager- Argentina (Buenos Aires)

Regulatory Affairs Manager- Argentina (Buenos Aires)

19 oct
|
Roche Holding
|
Buenos Aires

19 oct

Roche Holding

Buenos Aires

Bei Roche kannst du ganz du selbst sein und wirst für deine einzigartigen Qualitäten geschätzt. Unsere Kultur fördert persönlichen Ausdruck, offenen Dialog und echte Verbindungen. Hier wirst du für das, was du bist, wertgeschätzt, akzeptiert und respektiert. Dies schafft ein Umfeld, in dem du sowohl persönlich als auch beruflich wachsen kannst. Gemeinsam wollen wir Krankheiten vorbeugen, stoppen und heilen und sicherstellen, dass jeder Zugang zur Gesundheitsversorgung hat – heute und in Zukunft. Werde Teil von Roche, wo jede Stimme zählt.

Die 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 integral 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.
- Overse

📌 Regulatory Affairs Manager- Argentina (Buenos Aires)
🏢 Roche Holding
📍 Buenos Aires

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