Oncology Regulatory Affairs Manager

2 semanas atrás

São Paulo, Brasil Johnson & Johnson Innovative Medicine Tempo inteiro

Oncology Regulatory Affairs Manager role at Johnson & Johnson Innovative Medicine We are searching for the best talent for an Oncology Regulatory Affairs Manager position, based in São Paulo, Bogotá or Mexico City. Purpose Regulatory Affairs Manager for the Latin America region, responsible for regulatory science and crafting strategies to advance projects in early research stages, develop submissions and approvals for initial marketing authorization applications, and manage lifecycle of assigned products. This Role Involves Working closely with local, global, and cross‑functional partners to ensure compliance and outstanding strategies for assets in the market. Preparing, submitting, and maintaining filings. Collaborating with senior department members to expedite commercialization of new technologies, indications, and line extensions. Providing early inputs to identify barriers and needs to craft global development plans. Interpreting local and international requirements. Providing support to cross‑functional teams and representing the company in interactions with authorities and industry associations. Collaborating with teams of varied strengths to ensure alignment and consistency in strategies and submissions. Qualifications Bachelor’s degree completed. Proven ability in regulatory affairs, focusing on the pharmaceutical or biotechnology industry, keeping abreast of trends, developments, technologies, and competitive landscape. Solid understanding of requirements and guidelines in the Latin America region. Ability to analyze information to develop effective scenario planning, prioritize scenarios, and respond proactively to customer needs and company strategy. Confirmed experience leading submissions and interactions with regulatory authorities. Excellent communication and interpersonal skills, able to work optimally in a cross‑functional environment. Able to work independently and balance multiple projects simultaneously. Proficiency in English and Spanish required; proficiency in Portuguese is a plus. Required Skills 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 All Job Posting Locations Bogotá, Distrito Capital, Colombia Mexico City, Mexico São Paulo, Brazil #J-18808-Ljbffr

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