Regulatory Affairs Lead, Chile & Ecuador

MX16 (FCRS = MX016) Sandoz S.A. de C.V.; Santiago; Presencial; CLP 48.000.000 - 72.000.000; Jornada completa

Descripción de la vacante

MX16 (FCRS = MX016) Sandoz S.A. de C.V. seeks a Senior Regulatory Affairs professional to direct regulatory strategy and lead interactions with Health Authorities in major regions.

You will coordinate dossier submissions, provide guidance on labeling and compliance, and act as a regulatory liaison throughout product lifecycles, ensuring timely approvals and ongoing market access. The role requires a pharmacy degree or related field with 5+ years in regulatory affairs, strong negotiation skills,

Formación

• Pharmacy degree or related field.
• 5+ years in Regulatory Affairs or equivalent.
• Experience engaging with Health Authorities and submitting dossiers.

Responsabilidades

• Lead regulatory strategy and manage HA interactions for major regions.
• Coordinate dossier submissions and briefing books to expedite approvals.
• Provide guidance on regulatory labeling, manufacturing changes, and compliance requirements.
• Mentor teams and ensure alignment with global regulatory plans.

Conocimientos

Clinical Trials

Cross-Functional Teams

Detail-Oriented

Drug Development

Lifesciences

Negotiation Skills

Problem Solving Skills

Regulatory Compliance

Risk Management

Educación

Pharmacy degree or related field

Descripción del empleo

MX16 (FCRS = MX016) Sandoz S.A. de C.V. seeks a Senior Regulatory Affairs professional to direct regulatory strategy and lead interactions with Health Authorities in major regions.

You will coordinate dossier submissions, provide guidance on labeling and compliance, and act as a regulatory liaison throughout product lifecycles, ensuring timely approvals and ongoing market access. The role requires a pharmacy degree or related field with 5+ years in regulatory affairs, strong negotiation skills,