Regulatory Affairs Associate
hace 1 día
In the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico.**Responsibilities**:Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.Contribute to the production of client administrative documents to be included in regulatory submissionsCompile regulatory dossiers in accordance with national requirements.Systems Management and AdministrationDocument and track regulatory submissions and regulatory authority approval.Provide regulatory support to clients and associate companiesLiaise with sponsor head-office and affiliate departments on regulatory issues.Provide review of packaging texts.Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory servicesEducation & ExperienceBachelor’s or higher graduate degree in a science related field, or equivalent experience1 to 3 years of experience in Regulatory AffairsExperience in LATAM region regulationsProfileHard/Technical skills:Knowledge of LATAM regulationsGood understanding of regulatory tracking database software, eDMS, MS Word, MS ExcelSoft skills:Excellent organizational and interpersonal skillsAbility to work well within a teamProcess oriented with good attention to detailEffective oral and written communication skillsSense of responsibility and meeting deadlinesFluency in SpanishGood command of English
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Associate Director, Regulatory Affairs
hace 4 días
Desde casa, México IQVIA A tiempo completo**We are looking for a forward-thinking, metrics-driven leader with study start-up experience, who has served as a Department Head and brings cross-functional and strategic expertise. This role will involve managing 8-10 direct reports and requires strong financial acumen to drive success.**Job OverviewLine Management responsibilities for a team of...
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Regulatory Affairs Associate
hace 6 días
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Associate to join our teams in Mexico. **Responsibilities**: Assisting with the preparation of LATAM Marketing Authorization Applications Preparation and submission of documentation for post-authorization activities Compile Dossier as per country requirements Education &...
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Regulatory Affairs Specialist
hace 3 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Regulatory Affairs Specialist
hace 3 semanas
Desde casa, México ProductLife Group A tiempo completoIn the context of a new project, we are looking for a Regulatory Affairs Specialist to join our teams in Mexico/LATAM.**Responsibilities**:Provide guidance and support about Mexican and Central America legislationContribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal...
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Regulatory Affairs Manager
hace 3 semanas
Desde casa, México Atnahs A tiempo completo**Based in Mexico (remote)**:**Salary: Competitive + Bonus + Benefits**:If you are an agile, committed, and innovative regulatory affairs professional in the pharmaceuticals sphere, then we want to hear from you!Join us to help improve peoples’ lives and make healthcare better for everyone!**Why Pharmanovia?**:Pharmanovia is a dynamic, fast-growing...
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Regulatory Affairs Specialist, Latam
hace 3 semanas
Desde casa, México IQVIA A tiempo completo**POSITION TITLE**: Regulatory Affairs Specialist**REPORTS TO**: Manager, Regulatory Affairs or Designee**BASIC FUNCTIONS**:**ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES**:- Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information,...
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Regulatory Affairs Associate
hace 4 días
Desde casa, México Parexel A tiempo completoAn Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and Supervisor, taking...
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Regulatory Affairs Specialist
hace 4 días
Desde casa, México ICON A tiempo completoAs a Regulatory Affairs Specialist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.**What you will be doing**:- Regulatory advice to drug development is key to ensuring our clients pursue first time right strategies to overall product development and to clinical programme...
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Regulatory Affairs Associate
hace 3 semanas
Desde casa, México Parexel A tiempo completoAs part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...
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Regulatory Affairs Specialist
hace 1 día
Desde casa, México IQVIA A tiempo completo**Job Overview****Essential Functions**:- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present...