Regulatory Affairs Specialist
4 semanas atrás
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Thermo Fisher Scientific. As a key member of our regulatory team, you will be responsible for ensuring compliance with local regulatory requirements and providing strategic advice to internal clients.
Key Responsibilities- Prepare and review local regulatory submissions, including MoH and EC applications, in alignment with our global submission strategy.
- Provide local regulatory strategy advice to internal clients, ensuring compliance with local regulations.
- Coordinate local SIA services and projects, ensuring timely completion and alignment with submission activities.
- Collaborate with internal functional departments to ensure site start-up activities are aligned with submissions and timelines.
- Enter and maintain trial status information onto PPD tracking databases in an accurate and timely manner.
- Maintain knowledge of PPD SOPs, client SOPs, and current regulatory guidelines applicable to services provided.
- Strong understanding of local regulatory requirements and guidelines.
- Excellent communication and project management skills.
- Ability to work independently and collaboratively as part of a team.
- Proficiency in PPD tracking databases and software.
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Quality Compliance Tempo inteiroJob Title: Regulatory Affairs SpecialistAt Quality Compliance, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with ANVISA and international standards.Key Responsibilities:* Prepare and submit regulatory documentation in compliance with...
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Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Sully's Steamers Johnson City Tempo inteiro**Regulatory Affairs Role Summary**At Sully's Steamers Johnson City, we are seeking a highly skilled Regulatory Affairs Specialist to coordinate, compile, and submit new drug/medical devices applications to regulatory agencies.**Key Responsibilities**Plan, conduct, and coordinate JJV regulatory activities for Brazil.In partnership with RA management,...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Sully's Steamers Johnson City Tempo inteiro**Regulatory Affairs Role Summary**We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Sully's Steamers Johnson City. In this role, you will be responsible for coordinating, compiling, and submitting new drug/medical devices applications to regulatory agencies.**Key Responsibilities:**Plan, conduct, and coordinate JJV regulatory...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiroJob Title: Regulatory Affairs SpecialistJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Bristol Myers Squibb. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines, as well as developing and implementing strategies to maintain and improve...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Kenvue Tempo inteiroRegulatory Affairs Role OverviewKenvue is a leading company in the industry, and we are currently seeking a highly skilled Regulatory Affairs Specialist to join our team. As a Regulatory Affairs Specialist, you will play a critical role in ensuring that our products comply with all relevant regulations and guidelines.Key Responsibilities* Work closely with...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Intrials Clinical Research Tempo inteiroJob Title: Regulatory Affairs SpecialistAbout the Role:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Intrials Clinical Research. As a Regulatory Affairs Specialist, you will be responsible for managing regulatory and start-up activities for clinical trials in Latin America.Key Responsibilities:- Manage regulatory and...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Bristol Myers Squibb Tempo inteiroJob SummaryBristol Myers Squibb is seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with regulatory requirements and guidelines.Key ResponsibilitiesPrepare and submit regulatory filings, including BLA, NDA, and LCM, to ANVISA and...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Baxter Tempo inteiro**Transforming Healthcare through Regulatory Excellence**Baxter is a leading medical technology company that has been pioneering significant medical innovations for over 85 years. Our mission is to save and sustain lives, and we're looking for a talented Regulatory Affairs Specialist to join our team.As a Regulatory Affairs Specialist at Baxter, you will be...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Thermo Fisher Scientific Tempo inteiroJob Title: Senior Regulatory Affairs SpecialistWe are seeking a highly skilled Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is an excellent opportunity to further develop your regulatory career and expertise in a global clinical trial setting.In this role, you will be a pivotal team member with regulatory...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Ceva Animal Health, Llc Tempo inteiro**Regulatory Affairs Specialist**Ceva Animal Health, Llc is a global leader in animal health, and we're committed to ensuring the highest possible level of care and well-being for farm animals, companion animals, and wildlife.We're seeking a Regulatory Affairs Specialist to join our team, responsible for maintaining the filing of regulatory documents,...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Kenvue Tempo inteiroJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at Kenvue. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the compliance of our products with regulatory requirements across Latin America.Key ResponsibilitiesCollaborate with cross-functional teams to ensure regulatory complianceDevelop...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Kenvue Tempo inteiroKenvue is a leading company in the development and manufacturing of everyday care products. We are currently seeking a highly skilled Regulatory Affairs Specialist to join our team in Latin America.Key Responsibilities:Collaborate with local and regional Regulatory Affairs teams to ensure seamless operations.Develop and implement robust regulatory strategies...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroTeleflex - Regulatory Affairs SpecialistAbout Teleflex IncorporatedTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. We apply purpose-driven innovation – a relentless pursuit of identifying unmet clinical needs – to benefit patients and healthcare providers. Our...
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Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiroKenvue is seeking a highly skilled Regulatory Affairs Specialist to join our team. This role reports into Manager, Global Reg Strategic Compliance and is based at Brazil. São Paulo Capital.As a Regulatory Affairs Specialist, you will be responsible for developing and maintaining PowerBI Dashboards and reports for Regulatory systems and databases. You will...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroAbout Teleflex IncorporatedTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in various fields, including vascular and interventional access, surgical, anesthesia, cardiac care, urology, emergency medicine, and respiratory...
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Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroAbout TeleflexTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology, emergency medicine,...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Novo Nordisk Tempo inteiroAs a Regulatory Affairs Specialist at Novo Nordisk, you will play a critical role in ensuring the company's compliance with international and local regulations on Clinical Trials. Your responsibilities will include developing informed consent forms and regulatory dossiers, managing the submission and approval process for trial dossiers, and handling safety...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Gilead Sciences Tempo inteiroJob DescriptionGilead Sciences is seeking a highly skilled Regulatory Affairs professional to join our team in Sao Paulo. As a Regulatory Affairs Specialist, you will play a critical role in ensuring the development and execution of robust regulatory strategies while maintaining regulatory compliance.Key Responsibilities:Support the definition, setting, and...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroRegulatory Affairs AnalystTeleflex is a global provider of clinically effective medical technologies designed to improve the health and quality of people's lives. Our portfolio is diverse, with solutions in the fields of vascular and interventional access, interventional cardiology, surgical, anesthesia, cardiac care, interventional urology, urology,...
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Regulatory Affairs Specialist
4 semanas atrás
São Paulo, São Paulo, Brasil Teleflex Tempo inteiroAbout TeleflexTeleflex is a global leader in the development and manufacture of medical devices. Our portfolio includes a wide range of products, from vascular and interventional access to surgical, anesthesia, and cardiac care. We are committed to improving the health and quality of life for patients around the world.Job SummaryThe Pl. Regulatory Affairs...