Chile & Ecuador Regulatory Affairs Head

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

• Is responsible for implementing regulatory strategy and managing operational activities for assigned major/ large regions.
• Provides input into global regulatory strategy and contributes to Regulatory Functional Plan (RFP) and Seed Document, or their equivalents, including identification of gaps or risks in global strategic plan for assigned regions.
• Partners with regions to align on regulatory strategy in order to fulfil business objectives -Implements RFP across assigned regions.
• Determines requirements and sets objectives for Health Authority (HA) interactions with DRA GPT representative and/or GTAL.
• Facilitates preparation and finalization of briefing books and contributes to preparation of summary documents.
• Develops and implements plans for timely response to HA requests and coordinates responses.
• May serve as local HA liaison depending on location (e.g., FDA or EMA).
• Drives coordination, planning, and submission of dossiers in assigned regions worldwide.
• Review of global dossier summary documents.
• Develops and implements plans to avoid/minimize clock stops during submission review.
• Reviews, approves and submits Clinical Trial Applications (CTAs) and Investigational New Drugs (INDs).
• Reviews and submits Risk Management Plans.
• May lead negotiations for regional approvals independently or with DRA GPT representative and/or GTAL.
• Responsible for facilitating timely submission and approval of dossier with HAs under the guidance of the DRA GPT representative and/or GTAL.
• Contributes to and often leads the development of departmental goals and objectives.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Successful implementation of global regulatory strategy for timely submissions and approvals with the best possible labels based on available data.
• Identification of main HA issues -Participation in relevant regulatory Boards leading to valuable input from these Boards.
• Successful Participation in HA interactions to achieve business objectives.
• Adherence to Sandoz policy and guidelines -Project & stakeholder feedback
• Pharmacy degree or a related field.
• More than 5 years of experience leading a Regulatory Affairs function.
• Previous experience working 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.

This site is intended for a global audience