Chile & Ecuador Regulatory Affairs Head

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

Job Description Summary

• Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of pending registration and answers any questions. Serves as a regulatory liaison on the project team throughout the product lifecycle. Ensures rapid and timely approval on of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices. Serves as regulatory representative to marketing or research project teams and government regulatory agencies. Provides advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations. Coordinates, reviews, and may prepare reports for submission.

Job Description

Major accountabilities

• 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.
• Adherenceto Sandoz policy and guidelines -Project & stakeholder feedback

Minimum Requirements

Work Experience

• Pharmacy degree or a related field.
• More than 5yearsofexperienceleadingaRegulatory Affairs function.
• Previousexperience 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.

Languages

English.

Skills Desired

Clinical Trials, Cross-Functional Teams, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Problem Solving Skills, Regulatory Compliance, Risk Management