Chile & Ecuador Regulatory Affairs Head

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

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. Adherence to Sandoz policy and guidelines -Project & stakeholder feedback

Minimum Requirements:

Work Experience: 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. Provide your feedback on BizChat Languages : English.

Skills Desired

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

Our Purpose here at Sandoz is pioneering access for patients. As the global leader in 'off-patent' high quality medicines, we are able to make medicine more affordable and accessible. Our broad global portfolio comprises of approximately 1,300 quality biosimilar and generic medicines, enabling us to provide more than 900 million patient treatments across 100+ countries per year, and while we are proud of this achievement, we have an ambition to do more! Powered by our talented and ambitious colleagues, who, in return for dedication and skills, experience a flexible, collaborative & inclusive culture where diversity of thought is welcomed and where personal growth is nurtured!