Director, Regulatory Affairs
3 semanas atrás
As Head of LATAM, Manage and oversee assigned Regulatory Affairs activities within Brazil, South Latin America and other Latin America Countries and may have financial budget responsibilities. Develop a robust talent development plan in alignment with functional growth strategies of the department.
Identify risk, develop and lead in the implementation of broad and more complex regulatory affairs strategies within countries which may include negotiations with internal and external parties
Plan and direct complex activities with large scale or significant business impact with the accountability for successful completion of all deliverables. Lead in identifying risk, developing mitigation strategies, alternative solutions, resolving issues in collaboration with cross functional and/or matrix teams while ensuring regulatory compliance
Handle complex Regulatory Compliance issues and ensure these are communicated to the appropriate levels of the country, regional and functional management.
Analyze local regulatory trends and market intelligence information;
Advise and make recommendations to regional business organization and management on the potential opportunities, high impact risks of regulatory changes implementation;
Act as a strategic thought partner and the lead RA partner with stakeholders to develop the RA strategy to achieve its current and future business objectives.
Represent RA function through active participation at Country/Region Leadership Teams and Management reviews, grasping Business strategy and partnering with RA input.
This includes updating the BU & Marketing leaders, rCoE and RA Head on the New Product Introduction project, impact of product changes and license renewals timelines and status. Act as interface with Quality Assurance, RA Centre of Expertise and Business RA Leadership Teams for region and business of responsibility
Manage and submit local in-country Product & Clinical Trial Submissions when applicable. Lead Q&As with Local CA and strive to get early approvals. Obtain on time product approvals Managing Customer & Sales organization requests.
Build and maintain relationships and RA Agenda with local regulatory authorities and Advocate in National and Regional trade associations to gain market intelligence information; acts as a point of contact/Key
-
Brazil Regulatory Affairs Director
2 semanas atrás
São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$1.200.000 - R$1.500.000We are seeking an experienced and strategic leader to head our regulatory affairs department in Brazil.About the RoleThis is a unique opportunity to drive the growth of our business by ensuring compliance with regulations and developing innovative registration strategies.The successful candidate will be responsible for designing and implementing the...
-
Regulatory Affairs Manager
1 semana atrás
São Paulo, São Paulo, Brasil Essity Tempo inteiro**Regulatory Affairs Manager LATAM**:**Trabalhar na Essity não é apenas uma carreira, é uma chance de tornar o mundo um lugar mais saudável, higiênico e seguro. Com inovações impactantes, juntamente com soluções sustentáveis, nos esforçamos para alcançar mais pessoas a cada ano com as soluções necessárias e essenciais para o bem-estar.****A...
-
Associate Director, Regulatory Affairs
1 semana atrás
São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiroQuality Assurance Regulatory Affairs ManagerJob Summary: Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents...
-
Senior Regulatory Affairs Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil beBeeProfessional Tempo inteiro R$80.000 - R$120.000Regulatory Affairs ProfessionalWe are seeking a skilled Regulatory Affairs professional to fill this challenging role in Brazil.
-
Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil Johnson & Johnson Tempo inteiro**Job Function**:Regulatory Affairs Group**Job Sub Function**:Regulatory Affairs**Job Category**:Professional**All Job Posting Locations**:São Paulo, BrazilOur expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the...
-
Governmental & Regulatory Affairs Specialist
3 semanas atrás
São Paulo, São Paulo, Brasil UBS Tempo inteiroGovernmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Governmental & Regulatory Affairs Specialist Join to apply for the Governmental & Regulatory Affairs Specialist role at UBS Job Reference # BRJob TypeFull TimeYour roleAre you curious, have attention to detail and the ability to...
-
Regulatory Affairs Specialist
Há 7 dias
São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$88.144 - R$114.159Regulatory Affairs ExpertDeliver exceptional regulatory services that drive business excellence and patient access to life-changing medicines. You will be a key player in shaping the future of our Regulatory Affairs department, ensuring compliance with local and global regulations, and advancing our mission to bring innovative treatments to patients...
-
Regulatory Affairs Specialist
1 semana atrás
São Paulo, São Paulo, Brasil beBeeRegulatoryAffairs Tempo inteiro R$50.000 - R$70.000As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulations and laws related to the submission of clinical trials to health authorities in Brazil.Job DescriptionThis role involves managing and coordinating the regulatory submission strategy for multiple clinical trials in Brazil. You will be working closely with teams...
-
Regulatory Affairs Specialist
2 semanas atrás
São Paulo, São Paulo, Brasil Alimentiv Inc. Tempo inteiroResponsible for the day-to-day activities and delivery of Global Regulatory Affairs support services. Role will include management of clinical trial applications to Competent Authorities, Ethics Committees and Regulatory Agencies, and the research, review and reporting on applicable global regulations and requirements. Develop stakeholder tools,...
-
Manager, Regulatory Affairs
1 semana atrás
São Paulo, São Paulo, Brasil buscojobs Brasil Tempo inteiroQuality Assurance Regulatory Affairs ManagerJob Summary: Highridge Medical creates the world's most innovative spinal solutions across the spectrum from Motion Preservation to MIS to Bone Healing to Core Spine. Working at Highridge Medical is not just work. Life at Highridge Medical is purpose driven. Every day, you have the privilege of using your talents...
