Regulatory Affairs Analyst
Há 2 horas
Job Title: Regulatory Affairs (RA) Analyst About the Position The Regulatory Affairs Analyst will be responsible for managing regulatory submissions and ensuring compliance with local and international regulatory requirements.This role plays a key part in supporting new product registrations, post-marketing activities, and regulatory strategy execution within the pharmaceutical domain.Key Roles & Responsibilities Prepare, review, and submit high-quality CTD dossiers for new drug product registrations and post-marketing variations in compliance with regulatory requirements.Prepare and respond to Deficiency Letters issued by ANVISA, ensuring timely and accurate submissions.Conduct risk assessments and gap analyses to enhance regulatory processes and improve dossier quality.Develop and implement regulatory strategies for Pharmaceutical Equivalence Studies and Biowaivers, including coordination of outsourcing activities.Support and monitor the importation process in line with regulatory compliance requirements.Evaluate regulatory feasibility and identify potential risks or requirements to support project execution.Qualifications & Experience Minimum 5 years of experience in Regulatory Affairs or Technical Documentation within the pharmaceutical industry.Bachelor's degree or higher in Pharmacy, Chemistry, Biology, Biomedicine, or a related field.Strong working knowledge of ANVISA regulations, as well as international regulatory guidelines and processes.Proven ability to manage regulatory documentation with accuracy, attention to detail, and compliance focus.
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Director Of Regulatory Affairs
1 dia atrás
Belo Horizonte, Brasil Multinational Pharmaceutical Company Tempo inteiroThe Director, Regulatory Affairs Latin America is responsible for developing regulatory strategies and providing guidance to product development and commercial teams in support our products Portfolio.Key Responsibilities Prepares regulatory product strategies.Prepares and manages regulatory submissions, including new applications and amendments, annual...
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Senior Regulatory Affairs Specialist
3 semanas atrás
Belo Horizonte, MG, Brasil beBeeCompliance Tempo inteiroRegulatory Governance Specialist This position involves managing regulatory compliance on a full-time hybrid basis in Belo Horizonte, MG. The successful candidate will have an in-depth understanding of Regulatory Compliance and be familiar with regulatory requirements for the medical device industry. The job requires analytical skills, experience working...
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Regulatory Affairs Specialist
Há 6 horas
Belo Horizonte, Brasil Upsilon Global Tempo inteiroFreelance Regulatory & Study Start-Up Specialist – LATAM - Brazil, Chile and ArgentinaUpsilon Global are seeking a freelance regulatory and start-up specialist with solid experience in Ethics Committee submissions for observational studies in LATAM, specifically Chile, Argentina and Brazil.The role will provide centralized oversight and execution of local...
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Regulatory Manager
2 semanas atrás
Belo Horizonte, Brasil Acandis GmbH Tempo inteiroCompany Description Acandis GmbH, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory manager
3 semanas atrás
Belo Horizonte, Brasil Acandis GmbH Tempo inteiroCompany Description Acandis Gmb H, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory Manager
3 semanas atrás
Belo Horizonte, Brasil Acandis GmbH Tempo inteiroCompany Description Acandis GmbH, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory Manager
3 semanas atrás
Belo Horizonte, Brasil Acandis GmbH Tempo inteiroCompany Description Acandis GmbH, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory Manager
3 semanas atrás
Belo Horizonte, Brasil Acandis GmbH Tempo inteiroCompany Description Acandis GmbH, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory Manager
Há 11 horas
Belo Horizonte, Brasil Acandis Gmbh Tempo inteiroCompany Description Acandis GmbH, founded in ****, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
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Regulatory Manager
Há 2 dias
Belo Horizonte, Minas Gerais, Brasil Acandis GmbH Tempo inteiroCompany DescriptionAcandis GmbH, founded in 2006, is a German medical device company specializing in stroke prevention and treatment. Dedicated to developing innovative solutions for unmet clinical needs, Acandis aims to improve patient outcomes and enhance stroke care for neurointerventionalists worldwide. Based in Pforzheim, near the Black Forest in...
