RA Manager
2 semanas atrás
- Survey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.
- Responsible for the review, analysis and filing of new records before the regulatory entity in each country.
- Responsible for renewals and monitoring of health records.
- Responsible for responding to the requests or requirements of the territorial entities or legal entities that have any need for information, complaint or disagreement with the products and manufacturing processes.
- Responsible for updating regulatory legislation for the countries in charge at the level: technical, regulatory, quality, pharmacovigilance and marketing.
- Guarantee those responsible for handling medicines the application of good manufacturing practices (GMP)
- Coordination of brands, dossiers and patents within the company
- Take charge of product quality issues in the company's internal and external processes ex : complaints, Discussion with ANVISA, etc
- Manage internal and external processes such as: trades, paperwork, stock depletions for the areas of regulatory affairs and quality.
- Guarantee the updating of the BPM, BPL systems regarding: sanitary records, technical sheets, safety sheets and commercial information.
- Manage communication and coordination with the manufacturer for certificate procedures.
- Comply with the documentation and information provided by the Head Office in India vs. the related information of each health registry in the countries in charge.
- Responsible for the review of packaging and its materials to ensure compliance with regulations in each territory.
- Coordination with the quality area of the logistics operator of the packaging for additional coding processes, packaging changes, inclusion of inserts.
- Co ordinating with responsible PV person to be align with regulatory requirement
- Delegating work to the regulatory affairs team for smooth operations with respect to submissions and life cycle management of the drug product.
- Knowledge and functional skills to exercise the position:
- Experience of 5 to 10 years in the industry of pharmaceutical products for human use.
- Pharmaceutical chemist professional.
- Knowledge of regulatory affairs and quality requirements per regulatory requirement.
- Requirement for dossier submissions for different dosage forms like tablets, Injections and oral solutions. Have complete update knowledge on the RDC's and application of the same.
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Senior Associate, Finance
3 semanas atrás
São Paulo, Brazil, BR Rainforest Alliance Tempo inteiroPosition Summary:The Senior Associate, Finance & Administration, Brazil is a key member of the Regions and Support units (Finance & Administration) teams. The Senior Associate, Finance & Administration will handle the day-to-day accounting process supporting the Brazil team. They will be responsible for compliance with local tax requirements in coordination...
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City Manager
5 meses atrás
Sao Paulo, Brasil Resident Advisor Tempo inteiro**Resident Advisor is the world’s foremost platform for discovering electronic music, artists and events. Described by the NY Times as “the most influential electronic music site in the world”, every month RA reaches more than 5m people across its web, mobile and app properties.** The City Manager's primary focus is to support the local electronic...
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Regulatory Affairs Manager
5 meses atrás
São Paulo, Brasil JM Huber Corporation Tempo inteiroSummary The Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (HAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and / or growth and right to...
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General Manager
5 meses atrás
Sao Paulo, Brasil Resident Advisor Tempo inteiroResident Advisor is the world’s foremost platform for discovering electronic music, artists and events. Described by the NY Times as “the most influential electronic music site in the world”, every month RA reaches more than 5m people across its web, mobile and app properties. The General Manager role is focused on driving the holistic growth and...
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Regulatory Affairs Manager
2 meses atrás
São Paulo, São Paulo, Brasil JM Huber Corporation Tempo inteiroJob SummaryThe Regulatory Affairs Manager supports the Regulatory Management System (RMS) for the Specialty Agriculture Solutions (SAS) business unit and Huber Engineered Materials (HEM) internal and external customer systems. The RA Manager provides expertise for regulatory affairs projects supporting business maintenance and/or growth and right to operate...
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RA Manager
2 semanas atrás
São Paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country. Responsible for the review, analysis and filing of new records before the regulatory entity in each country. Responsible for renewals and monitoring of health records. Responsible for responding to the requests or...
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RA Manager
2 semanas atrás
são paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...
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RA Manager
Há 12 horas
são paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...
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RA Manager
2 semanas atrás
são paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country. Responsible for the review, analysis and filing of new records before the regulatory entity in each country. Responsible for renewals and monitoring of health records. Responsible for responding to the requests or...
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Ra Manager
2 semanas atrás
São Paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...
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RA Manager
2 semanas atrás
São Paulo, Brasil MSN Laboratories Tempo inteiroSurvey and implementation of processes, policies and procedures that guarantee compliance and continuity of Regulatory Affairs in each country.Responsible for the review, analysis and filing of new records before the regulatory entity in each country.Responsible for renewals and monitoring of health records.Responsible for responding to the requests or...
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Brazil Financial Operations Manager
2 semanas atrás
São Paulo, São Paulo, Brasil Rainforest Alliance Tempo inteiroJob SummaryThe Brazil Financial Operations Manager will be a key member of our team, handling daily accounting processes, ensuring compliance with local tax requirements and donor guidelines. This role will be responsible for coordinating with our legal team, Country Director, and local staff to maintain accurate and detailed accounting and payroll...
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Electronic Music Scene Ambassador
4 semanas atrás
São Paulo, São Paulo, Brasil Resident Advisor Tempo inteiroJob Title: City Manager São PauloResident Advisor is seeking a highly motivated and embedded individual to support the local electronic music scene in São Paulo through content and editorial as part of the RA Contributor Network.Key Responsibilities:Develop and maintain a deep understanding of the São Paulo electronic music scene, including its key...
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Regulatory Affairs Manager
5 meses atrás
Sao Paulo, Brasil Unilever Tempo inteiro**Unilever is currently hiring for a Regulatory Affairs Manager based in São Paulo.** **Unilever** is the place where you can bring your purpose to life with the work that you do - creating a better business and a better world. We are looking for talents that would like to join this exciting journey with us. Our **R&D Brazil Beauty & Wellbeing** team is...
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Medical Manager Hematology Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiroJoin Our Team as a Medical Manager HematologyWe are seeking a highly skilled Medical Manager Hematology to join our team in Sao Paulo, Brasil. As a Medical Manager Hematology, you will play a critical role in developing and executing the local medical strategy for in-market and pipeline products.Key Responsibilities:Lead scientific discussions with key...
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Senior Technical Manager
2 semanas atrás
São Paulo, São Paulo, Brasil Bi Animal Health Brasil Ltda Tempo inteiroJob SummaryWe are seeking a highly skilled Senior Technical Manager to lead our technical team and drive the development of innovative solutions for the Large Animals Business Unit. The successful candidate will be responsible for managing technical strategies, budget, and operations, and will work closely with internal and external stakeholders to build...
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Ra Manager
Há 5 dias
São Paulo, São Paulo, Brasil MSN Laboratories Tempo inteiroRegulatory Affairs Role at MSN LaboratoriesWe are seeking a skilled Regulatory Affairs professional to join our team at MSN Laboratories. The successful candidate will be responsible for ensuring compliance with regulatory requirements across various countries.Key Responsibilities:Review and analyze new regulatory records for submission to relevant...
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Regulatory Affairs Manager LATAM
3 semanas atrás
São Paulo, São Paulo, Brasil Merck Kgaa Tempo inteiroAt Merck KGaA, we are seeking a highly skilled Regulatory Affairs Manager LATAM to support our Life Science Division. As a key member of our team, you will be responsible for planning and executing regulatory activities to support portfolio expansion, working closely with global and regional functions, and stakeholders across the region and the globe.Key...
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Medical Manager Hematology
3 meses atrás
São Paulo, SP, Brasil Johnson & Johnson Tempo inteiroDE&I Statement For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve...
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Assistente de Assuntos Regulatórios
Há 1 mês
São Paulo, Brasil Kenvue Tempo inteiroCome work at the forefront of science - and help the brands you grew up with grow and evolve into the next generation. Regulatory Affairs Assistant (Fixed Term 24 Months) This position reports into Regulatory Affairs Manager and is based at Sao Paulo, Brazil or Sao Jose dos Campos, Brazil. Who we are At Kenvue, we realize the extraordinary power of...
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Regulatory Affairs Manager LATAM
3 semanas atrás
São Paulo, São Paulo, Brasil Merck Kgaa Tempo inteiroUnlock Your Potential as a Regulatory Affairs Manager LATAMAre you ready to take your career to the next level? We're seeking a highly skilled Regulatory Affairs Manager LATAM to join our team at Merck KGaA. As a key member of our Life Science Division, you will play a crucial role in supporting the implementation of portfolio expansion, working closely with...