LATAM Oncology Regulatory Affairs Lead

Johnson & Johnson; Ciudad de México; Presencial; MXN 1,528,000 - 1,979,000; Jornada completa

Descripción de la vacante

A leading healthcare company seeks an Oncology Regulatory Affairs Manager based in Mexico City. This role involves ensuring compliance with regulatory requirements in the Latin America region and leading submissions and interactions with regulatory authorities. The ideal candidate will have a bachelor's degree and experience in regulatory affairs within the pharmaceutical or biotechnology industry. Proficiency in English and Spanish is essential, and Portuguese is advantageous. Excellent communication skills and the ability to manage multiple projects are required.

Formación

• Proven ability in regulatory affairs, focusing on the pharmaceutical or biotechnology industry.
• Solid understanding of requirements and guidelines in the Latin America region.
• Confirmed experience in leading submissions and interactions with regulatory authorities.
• Excellent communication and interpersonal skills.
• Proficiency in English and Spanish is required, Portuguese is a plus.

Responsabilidades

• Working closely with partners to ensure compliance and strategies.
• Preparation, submission, and maintenance of filings.
• Collaborating with senior members to expedite commercialization.
• Providing early inputs to identify barriers.
• Interpreting local and international requirements.
• Supporting cross-functional teams and representing the company.

Conocimientos

Analytical Reasoning

Business Writing

Coaching

Fact-Based Decision Making

Industry Analysis

Legal Support

Process Improvements

Product Licensing

Public Policies

Regulatory Affairs Management

Regulatory Compliance

Regulatory Development

Regulatory Environment

Risk Assessments

Risk Compliance

Strategic Thinking

Technical Credibility

Educación

Bachelor’s degree completed

Descripción del empleo

A leading healthcare company seeks an Oncology Regulatory Affairs Manager based in Mexico City. This role involves ensuring compliance with regulatory requirements in the Latin America region and leading submissions and interactions with regulatory authorities. The ideal candidate will have a bachelor's degree and experience in regulatory affairs within the pharmaceutical or biotechnology industry. Proficiency in English and Spanish is essential, and Portuguese is advantageous. Excellent communication skills and the ability to manage multiple projects are required.