Oncology Regulatory Affairs Manager

hace 9 horas

Mexico City Johnson & Johnson Innovative Medicine A tiempo completo

Job Title Oncology Regulatory Affairs Manager Company Johnson & Johnson Innovative Medicine Locations Bogotá, Distrito Capital, Colombia; Mexico City, Mexico; São Paulo, Brazil Job Function Regulatory Affairs Job Category Professional Job Description At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Purpose Regulatory Affairs Manager for the Latin America region being responsible for the regulatory science and crafting the strategies to advance projects for early stages of research and develop submissions and approvals for initial marketing authorization applications and lifecycle management of the products assigned. This Role Involves Working closely with local, global, and other cross‑functional partners to ensure compliance with requirements and the outstanding strategies for the assets in the market. Performing the preparation, submission, and maintenance of filings. Collaborates with senior department members to expedite commercialization of new technologies, new indications and line extensions. Provides early inputs to identify barriers and needs to craft global development plan. Interpreting local and international requirements. Provides support to cross‑functional teams and represents the company in interactions with authorities and industry associations. Collaborates with teams with 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 with trends, developments, technologies and competitive landscape within the health care and pharmaceutical field. 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 to further the company’s strategy. Confirmed experience in leading submissions and interactions with regulatory authorities. Excellent communication and interpersonal skills, with the ability to work optimally in a cross‑functional environment. Ability to work independently and balance multiple projects simultaneously. Proficiency in English and Spanish required; proficiency in Portuguese a plus. Preferred 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 Seniority Level Not Applicable Employment Type Full‑time Industries Pharmaceutical Manufacturing #J-18808-Ljbffr

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