Strategic Regulatory Affairs Lead – Chile & Ecuador

Sandoz International GmbH; Santiago; Híbrido; CLP 84.349.000 - 149.953.000; Jornada completa

Descripción de la vacante

Sandoz International GmbH is seeking an experienced Regulatory Affairs leader to implement regulatory strategy and manage operations across major regions. You will align with regional teams on strategy, drive dossier submissions, and interface with health authorities as needed.

The role requires a pharmacy degree or related field and 5+ years of senior regulatory experience, with strong negotiation skills and collaboration across global teams. Location may involve local HA liaison duties.

Formación

• This role requires a Pharmacy degree or a related field.
• More than 5 years of experience leading a Regulatory Affairs function.
• Experience with professional associations, industry organizations, or trade chambers is preferred.
• Strong negotiation and influencing skills.
• Flexible, agile, and focused on team development to achieve ambitious business results.

Responsabilidades

• Implements regulatory strategy and manages operational activities for assigned major/large regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan and Seed Document.
• Partners with regions to align on regulatory strategy and implements RFP across regions.
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Reviews and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
• May serve as local HA liaison depending on location (e.g., FDA or EMA).
• Contributes to and leads development of departmental goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products.

Conocimientos

Regulatory strategy

Project leadership

Negotiation

Stakeholder management

Regulatory submissions

Educación

Pharmacy degree or related field

Descripción del empleo

Sandoz International GmbH is seeking an experienced Regulatory Affairs leader to implement regulatory strategy and manage operations across major regions. You will align with regional teams on strategy, drive dossier submissions, and interface with health authorities as needed.

The role requires a pharmacy degree or related field and 5+ years of senior regulatory experience, with strong negotiation skills and collaboration across global teams. Location may involve local HA liaison duties.