06 oct
|
Roche
|
Buenos Aires
06 oct
Roche
Buenos Aires
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 integral 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 ac
📌 Regulatory Affairs Manager- Argentina (Buenos Aires)
🏢 Roche
📍 Buenos Aires