LATAM Regulatory Lead – Submissions & Strategy

sandoz; Santiago; Presencial; CLP 93.458.000 - 130.841.000; Jornada completa

Descripción de la vacante

Sandoz is seeking an experienced Regulatory Affairs leader to guide global regulatory strategy and ensure timely submissions and approvals across major regions. You will interact with health authorities, prepare briefing materials, and coordinate cross-functional teams to support drug, biologics, or medical device products.

The role requires strong negotiation, risk management, and lifecycle regulatory expertise, with emphasis on fast-tracking approvals while maintaining compliance and robust

Formación

• Pharmacy degree or related field required.
• 5+ years of Regulatory Affairs leadership experience.
• Experience with professional associations or industry bodies preferred.

Responsabilidades

• Implement regulatory strategy and manage operational activities for major regions.
• Input into global regulatory strategy and contribute to regulatory plans.
• Partner with regions to align on regulatory strategy to meet business objectives.
• Determine requirements and set objectives for health authority interactions.
• Prepare briefing books and summary documents for HA interactions.
• Develop plans for timely responses to HA requests and coordinate responses.
• May serve as local HA liaison depending on location (FDA/EMA).
• Drive coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review global dossier summary documents.
• Develop plans to avoid delays during submission review.
• Review and submit CTAs and INDs.
• Review and submit Risk Management Plans.
• Lead negotiations for regional approvals when needed.
• Facilitate timely submission and approval of dossiers with HAs.

Conocimientos

Negotiation Skills

Detail Oriented

Problem Solving

Cross-Functional Teams

Lifesciences

Regulatory Compliance

Risk Management

Strong Communication

Educación

Pharmacy degree or related field

Descripción del empleo

Sandoz is seeking an experienced Regulatory Affairs leader to guide global regulatory strategy and ensure timely submissions and approvals across major regions. You will interact with health authorities, prepare briefing materials, and coordinate cross-functional teams to support drug, biologics, or medical device products.

The role requires strong negotiation, risk management, and lifecycle regulatory expertise, with emphasis on fast-tracking approvals while maintaining compliance and robust