Oncology Regulatory Affairs Manager
hace 20 horas
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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LATAM Oncology Regulatory Affairs Lead
hace 20 horas
distrito federal, México Johnson & Johnson A tiempo completoA 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...
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Strategic Oncology Regulatory Lead
hace 20 horas
distrito federal, México Johnson & Johnson Innovative Medicine A tiempo completoA leading healthcare company seeks an Oncology Regulatory Affairs Manager in Mexico City. This role involves ensuring compliance with regulations, preparing submissions, and collaborating with cross-functional teams. Candidates should have a Bachelor's degree, expertise in regulatory affairs, and proficiency in English and Spanish. The ideal candidate will...
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Manager, Regulatory Affairs
hace 20 horas
distrito federal, México Gilead Sciences, Inc. A tiempo completoManager, Regulatory Affairs page is loaded## Manager, Regulatory Affairsremote type: Onsite Requiredlocations: Mexico - Mexico Citytime type: Full timeposted on: Posted Todayjob requisition id: R At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer –...
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Manager, Regulatory Affairs
hace 20 horas
distrito federal, México Gilead A tiempo completoAt Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges,...
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Regulatory Affairs Leader, Mexico
hace 3 semanas
distrito federal, México Viatris A tiempo completoA global healthcare company in Mexico City is seeking a Lead of Regulatory Affairs to manage regulatory strategies and ensure compliance with local regulations. The ideal candidate must possess a scientific degree and over 10 years of experience in Regulatory Affairs. Responsibilities include leading a team, managing complex regulatory issues, and fostering...
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Regulatory Affairs Head
hace 4 semanas
distrito federal, México Johnson & Johnson A tiempo completoAt Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the...
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Regulatory Affairs Head
hace 20 horas
distrito federal, México Johnson & Johnson A tiempo completoAt 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...
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Senior Regulatory Affairs Manager – LATAM Submissions
hace 20 horas
distrito federal, México Gilead Sciences A tiempo completoA global biopharmaceutical company in Mexico City is seeking a skilled Regulatory Affairs professional with over 10 years of experience. This role involves coordinating regulatory submissions, ensuring compliance with local requirements, and providing expertise on labeling changes. The ideal candidate will have a degree in a scientific field, excellent...
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Senior Regulatory Affairs Manager – LATAM Submissions
hace 20 horas
distrito federal, México Gilead A tiempo completoA leading biopharmaceutical company in Mexico City is seeking a Regulatory Affairs professional with over 10 years of experience. The role involves coordinating regulatory submissions and ensuring compliance with local requirements. Candidates must have a degree in a scientific field and strong communication skills. This opportunity allows you to make a...
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Regulatory Affairs Senior Specialist
hace 4 semanas
distrito federal, México ICON A tiempo completoRegulatory Affairs Senior Specialist - Homebased in Estonia ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Regulatory...
