Regulatory Affairs Specialist
hace 1 día
**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 lessons learned and discuss customer comments;- Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;- May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;- May prepare and deliver regulatory training to IQVIA small groups or individuals;- Performs other tasks or assignments, as delegated by Regulatory management**Qualifications**:- Bachelor's/ Master´s Degree in Lifescience or related discipline- At least 3-4 years relevant experience- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;- Possesses a specific regulatory or technical expertise;- Ability to establish and maintain effective working relationships with coworkers, managers and clients;- Ability to work on several projects, with direction from senior staff as appropriate
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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 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 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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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 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
hace 4 días
Desde casa, México ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
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Regulatory Affairs Associate
hace 5 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 Associate
hace 1 día
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**: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...
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Medical Affairs Specialist
hace 4 días
Desde casa, México ICON A tiempo completoICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development...
