Regulatory Affairs Specialist for Global Compliance
hace 4 semanas
We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Bogota, Colombia. As a key member of our regulatory affairs department, you will be responsible for implementing programs, processes, and policies to support regulatory activities related to product regulatory, CMC regulatory, and scientific writing.
Key Responsibilities:- Develop and implement regulatory strategies to ensure compliance with health authorities' regulations;
- Prepare, submit, and follow up on medical affairs and authorities (MAA) registrations and archive registration files;
- Track product safety and maintain regulatory compliance with relevant legislation and regulations;
- Manage regulatory reporting/documentation for internal and external audiences, including gathering data, preparing, reviewing, and approving compliance documents;
- Minimum 3 years of experience in regulatory affairs;
- Bachelor's Degree in Pharmaceutical Chemistry or a related field;
- Intermediate-advanced English language proficiency;
- Advanced knowledge and application of regulatory principles and procedures;
- Ability to contribute to process design and improvement;
- An estimated salary range of $45,000 - $65,000 per year, depending on experience;
- A dynamic and supportive work environment;
- Ongoing training and professional development opportunities;
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Regulatory Affairs Specialist
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Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completoAbout CoopervisionCoopervision is a leading manufacturer of high-quality contact lenses and eye care products. We are dedicated to delivering innovative solutions that enhance the lives of our customers.Job SummaryWe are seeking an experienced Regulatory Affairs Specialist to join our team in Coopervision. This role will be responsible for ensuring...
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Regulatory Affairs Specialist: Product Compliance Expert
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Bogotá, Bogotá D.E., Colombia Coopervision A tiempo completo**Job Overview**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at CooperVision. This role will be responsible for ensuring compliance with regulatory requirements for our medical products.Salary: $80,000 - $110,000 per year, depending on experience and location.Job Description:The ideal candidate will have a strong background...
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Bogotá, Bogotá D.E., Colombia International Flavors & Fragrances A tiempo completoAbout Us:International Flavors & Fragrances is a global leader in taste, scent, and nutrition, offering innovative solutions to our customers worldwide. We value diversity, inclusion, and collaboration, fostering an environment where every employee can thrive.Job Overview:We are seeking an experienced Regulatory Affairs Specialist to join our team in...
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Global Medical Director for Regulatory Affairs
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Bogotá, Bogotá D.E., Colombia Ingepsy A tiempo completoWe are seeking an experienced and dynamic Global Medical Director of Regulatory Affairs to oversee and drive the strategic direction of medical and regulatory functions within our organization. This role emphasizes cross-functional collaboration, regulatory compliance, and external engagement to support product development, approval, and lifecycle...
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Regulatory Affairs Expert
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Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completoOverviewAt Medtronic, we pioneer healthcare technology to alleviate pain, restore health and extend life. Our team of 90,000+ passionate people experiment, create, build, improve and solve real-world problems.About the RoleThe Regulatory Affairs Specialist will lead regulatory activities for Latin America, ensuring compliance with regional regulations. This...
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Regulatory Affairs Specialist for Latin America
hace 3 días
Bogotá, Bogotá D.E., Colombia International Flavors & Fragrances Inc. A tiempo completoJob SummarySenior Regulatory Affairs Specialist focused on Product Compliance and advocacy, business, and customer support. Accountable for executing regulatory strategy in the Andean Region. Main focal point for the Functional Ingredients Business. Requires good relationship skills and knowledge of food regulations in the Andean region. Participation in...
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Strategic Medical Director for Global Regulatory Affairs
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Bogotá, Bogotá D.E., Colombia Novo Nordisk A tiempo completoWe are seeking an accomplished Senior Director to drive the strategic direction of medical and regulatory functions within our organization. This role emphasizes cross-functional collaboration, regulatory compliance, and external engagement to support product development, approval, and lifecycle management.Job SummaryThe ideal candidate will have a strong...
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Regulatory Affairs Specialist
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Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completo**Job Summary:**We are seeking an experienced Regulatory Affairs Specialist to join our Stryker Group team in LATAM. The successful candidate will be responsible for executing regulatory affairs activities, collecting and maintaining files on RAQA intelligence, and identifying the need for new regulatory procedures.**Key Responsibilities:**
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Dermatology Regulatory Affairs Specialist
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Regulatory Affairs Expert for Latin American Markets
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Bogotá, Bogotá D.E., Colombia Vantage Specialty Chemicals A tiempo completoVantage Specialty Chemicals is a leading supplier of naturally derived specialty ingredients and formulations catering to evolving industrial and consumer markets. Our chemistries, customer focus, and global footprint enable us to drive innovative solutions.We're a collaborative team committed to cultural diversity and continuous improvement. We empower our...
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Regulatory Affairs Specialist
hace 3 días
Bogotá, Bogotá D.E., Colombia Werfenlife Sa. A tiempo completoJob Description:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Werfenlife Sa. This is an exciting opportunity for a motivated and experienced professional to support the implementation and execution of regulatory and quality plans.Key Responsibilities:Support RAQA management with a business focus, ensuring compliance with...
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Regulatory Affairs Specialist for Latin America
hace 3 días
Bogotá, Bogotá D.E., Colombia Galderma Pharma S.A A tiempo completoGalderma Pharma S.A. offers a competitive salary of $80,000 to $100,000 per year in Bogotá, Colombia.About the JobWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Latam. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs and processes to support our activities in...
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Regulatory Affairs Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Werfen A tiempo completoOverviewJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to support the implementation and execution of regulatory and quality plans, and perform any regulatory activities for products marketed by Werfen.About the Role:Collaborate with RAQA management to drive business objectives.E nsure compliance with RAQA record management...
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Regulatory Affairs Lead
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Allergan A tiempo completoJob Overview: At Allergan, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for developing and executing regulatory strategies in alignment with global and affiliate regulatory colleagues.Responsibilities:Develop and execute regulatory strategiesRepresent area on global regulatory product teamsLead...
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Regulatory Affairs Specialist
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completoAt Medtronic, you can embark on a lifelong career of exploration and innovation, contributing to global healthcare technology and boldly addressing the most challenging health problems facing humanity. Our mission – to alleviate pain, restore health, and extend life – unites a global team of 90,000+ passionate people. As a Regulatory Affairs Specialist...
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Bogotá, Bogotá D.E., Colombia Medtronic A tiempo completoMedical Device Regulatory Affairs SpecialistWe are seeking a highly skilled Medical Device Regulatory Affairs Specialist to join our team at Medtronic. As a key member of our regulatory affairs department, you will play a crucial role in leading and preparing RA meetings, planning timelines, and registration strategies for medical devices in Latin...
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Senior Regulatory Affairs Professional
hace 5 días
Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completoStryker Corporation Job OpportunityWe are seeking a Senior Regulatory Affairs Specialist to join our team in Bogota D.C., Colombia.Estimated Salary: $60,000 - $80,000 per annum.About the RoleThis is a full-time position with hybrid work flexibility.The ideal candidate will have 4+ years of experience in regulatory affairs and a strong understanding of...
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Regulatory Affairs Director
hace 1 mes
Bogotá, Bogotá D.E., Colombia Abbvie A tiempo completoJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Abbvie. In this role, you will develop and execute regulatory strategies in alignment with Global and Affiliate Regulatory colleagues.Main Responsibilities:Provide strategic direction to support the development of compliant and competitive Regulatory programs.Manage...
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Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completoStryker Corporation is seeking a highly skilled Regulatory Affairs Specialist to join their team in Bogota D.C., Colombia. This is a full-time opportunity with a hybrid work arrangement.As a Senior Regulatory Affairs Specialist, you will be responsible for executing regulatory affairs activities in accordance with defined procedures and processes. This...
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Compliance Manager
hace 4 semanas
Bogotá, Bogotá D.E., Colombia Betsson Group A tiempo completoWe are seeking a seasoned Compliance Manager to oversee our regulatory obligations in specified markets. This role involves managing the application process for relevant regulators, license and compliance reporting, as well as acting as the primary liaison between our company and external authorities.