Regulatory Affairs Leader

hace 4 días

Insurgentes, México Novartis A tiempo completo

**Summary**:
Garantiza un sistema de documentación controlado, retención de registros y servicios de información, incluidos los procesos de retención de registros electrónicos de acuerdo con los requisitos reglamentarios. Asegura el cumplimiento de los requisitos de las agencias reguladoras. Mantiene el sistema de cambio de documentación técnica y no técnica. Asegura que existen procedimientos para clasificar y mantener registros. Interpreta y hace cumplir todos los requisitos de formato, estándares, políticas y procedimientos operativos de la documentación. Puede identificar los componentes de presentación, comunicar las normas de documentación y coordinar el montaje de los expedientes reglamentarios. Puede analizar y evaluar datos, extraer información pertinente, preparar resúmenes de información y resúmenes ejecutivos del material buscado. Puede mantener un amplio conocimiento de la información del producto y contactos continuos con clientes locales, regionales y divisionales.

**About the Role**:
**Key Responsibilities**
- Lead and manage mid
- to small-scale global regulatory submission projects, ensuring timely and compliant delivery
- Provide strategic input and regulatory intelligence to support global product development, registration, and lifecycle management
- Collaborate with cross-functional teams to implement and optimize global systems, tools, and processes for regulatory operations
- Ensure documentation complies with internal standards and external regulatory requirements, including formatting and retention policies
- Coordinate the preparation, review, and assembly of high-quality regulatory dossiers and submission components
- Analyze and interpret regulatory data, preparing executive summaries and abstracts to support decision-making
- Build and maintain strong relationships with internal stakeholders and external partners to align regulatory strategies

**Essential Requirements**
- Bachelor’s degree in life sciences, pharmacy, or a related scientific discipline
- Minimum 3 years of experience in regulatory affairs or related pharmaceutical industry role
- Proven ability to manage regulatory submissions and documentation in compliance with global standards
- Strong understanding of regulatory guidelines and documentation systems
- Experience working in cross-functional and multicultural teams
- Excellent written and verbal communication skills in English
- Strong analytical skills with the ability to interpret complex data and summarize key insights
- Proficiency in documentation tools and electronic records management systems

Division

Development

Business Unit

Innovative Medicines

Location

Mexico

Site

INSURGENTES

Company / Legal Entity

MX06 (FCRS = MX006) Novartis Farmacéutica S.A. de C.V.

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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