Manager, Regulatory Affairs
hace 3 días
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 – 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, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Experience Requirements:10+ years of experience in Regulatory Affairs or other relevant industry experience Degree in a scientific field is preferred. Specific Job Responsibilities Responsible for coordinating regulatory submissions sent to the distributor countries and responsible to prepare submission under the Mexican requirements. Responsible for submissions which may include CMC variations, labeling updates and renewals. Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics. Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling. May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses. Participate in group meetings and local and global product submission team meetings and present project status updates and strategy approaches to moderately complex programs/projects. Responsible under guidance of immediate manager for own self-development and acquisition of required regulatory skills and knowledge. Initiates or contribute to local process improvements which have an impact on the working of the Regulatory Affairs function or other departments. Excellent organization skills and ability to work on a number of projects with tight timelines is required. Excellent verbal and written communication skills and interpersonal skills are required. Must have in-depth knowledge of regulatory requirements in Mexico and some knowledge for Colombia, Argentina, Chile and Uruguay. Work is performed under minimal direction of a senior Regulatory Affairs professional. For Current Gilead Employees and Contractors Please apply via the Internal Career Opportunities portal in Workday. Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. #J-18808-Ljbffr
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Manager, Regulatory Affairs
hace 7 días
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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Regulatory Affairs Manager
hace 50 minutos
distrito federal, México Eli Lilly and Company A tiempo completoJoin to apply for the Regulatory Affairs Manager role at Eli Lilly and Company . At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life‑changing medicines to those who need them, improve...
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Oncology Regulatory Affairs Manager
hace 3 días
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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Manager, Regulatory Affairs
hace 7 días
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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Oncology Regulatory Affairs Manager
hace 7 días
distrito federal, México Johnson & Johnson Innovative Medicine A tiempo completoJob 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...
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LATAM Oncology Regulatory Affairs Lead
hace 7 días
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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distrito federal, México Teleflex A tiempo completoA global medical technology provider seeks a Regulatory Affairs Commercial Regional Manager in Mexico City. The successful candidate will lead a regional regulatory team focused on compliance and product registration within LATAM. This role demands a Bachelor's degree in relevant fields, fluency in English, and extensive experience in regulatory affairs....
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Regulatory Affairs Leader, Mexico
hace 4 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 Manager
hace 3 días
distrito federal, México Eli Lilly and Company A tiempo completoA global healthcare leader in Mexico City is seeking a Regulatory Affairs Manager to oversee regulatory activities for new product registrations and ensure compliance with local regulations. The role requires strong leadership skills to manage direct reports and collaborate with cross-functional teams, as well as cultivate relationships with government...
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Regulatory Affairs Head
hace 7 días
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...
