Novartis Farmacéutica | Regulatory Affairs Leader | victoria
hace 1 semana
-Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets & enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers.
About the RoleMajor accountabilities:
- Manages medium to small level global regulatory submission projects.
- Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
- Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
- Frequent internal company and external contacts.
- Represents organization on specific projects - Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
- Reporting of technical complaints/adverse events/special case scenarios related to Novartis products within 24 hours of receipt - Distribution of marketing samples (where applicable).
Key performance indicators:
- Adherence to Novartis policy and guidelines - Project & stakeholder feedback.
- Cross Cultural Experience.
- Functional Breadth.
- Operations Management and Execution.
- Project Management.
Skills:
- Clinical Study Reports.
- Data Analysis.
- Documentation Management.
- Operational Excellence.
- Regulatory Compliance.
-
victoria, México Novartis Farmacéutica A tiempo completoThe Director, Portfolio Advocacy LaCan will drive and execute targeted advocacy activities for policy priorities across the Novartis portfolio in Region LaCan, focusing on both in-market and launch products in alignment with regional commercial priorities. This role will be integral to driving collaboration closely with internal stakeholders and aligning...
-
Novartis Farmacéutica | Sourcing Manager
hace 7 días
victoria, México Novartis Farmacéutica A tiempo completoAbout the Role:To be responsible for leading the delivery of individual projects defined as part of the Annual Category Plan; focusing on project delivery with activities including requirements gathering, market analysis, qualifying and selecting suppliers with the relevant Business Partners and stakeholders, as well as non-sourcing projects such as demand...
-
Auditor Regulatory Compliance Specialist
hace 1 mes
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoGlobal Quality Regulatory Compliance Lead RoleAs a key member of the Novartis Farmacéutica team, the Global Quality Regulatory Compliance Lead will be responsible for leading, planning, conducting, documenting, and following up on global quality regulatory compliance audits and assessments of GCP/GPvP according to the requirements specified in the...
-
Novartis Farmacéutica | Director, Policy LaCan | victoria
hace 2 semanas
victoria, México Novartis Farmacéutica A tiempo completoThe Director, Policy LaCan (HCS) will proactively identify key policy trends across Region LaCan, collaborating closely with internal and external stakeholders, and shaping policy insights and recommendations in alignment with Country PA heads. This role will also play a crucial role in developing and disseminating key policy insights to empower country...
-
Senior IT Assurance Specialist
hace 3 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoAbout the RoleNovartis Farmacéutica is seeking a highly experienced Senior IT Assurance Specialist to join its team. As a key member of the organization, you will play a crucial role in ensuring the efficiency and effectiveness of IT Application Controls across the company's IT landscape.Key Responsibilities:Co-design, improve and drive the efficiency and...
-
Regulatory Affairs Leader
hace 1 mes
victoria, México Healthcare Businesswomen’s Association A tiempo completoJob Description Summary Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures...
-
Lead Auditor for Global Quality Regulatory Compliance
hace 3 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoJob OverviewThis role is responsible for leading and supporting the execution of global quality regulatory compliance audits and assessments, ensuring alignment with strategic direction and driving implementation of applicable actions.Key Responsibilities:- Support the development of a risk-based audit strategy and programme- Lead and conduct global quality...
-
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoCompany OverviewNurturing a culture of excellence in healthcare innovation, Novartis Farmacéutica empowers visionary leaders to drive transformative change. As a globally recognized leader in pharmaceuticals, our company prides itself on fostering a collaborative environment where talent thrives.Salary: $140,000 - $180,000 per yearOur compensation package...
-
Senior Team Leader Float
hace 4 semanas
victoria, México Novartis Farmacéutica A tiempo completoAs the Float Senior Supervisor, you will be working under the direction of the Director of Operations Mexico. This position is responsible for supporting the day-to-day operations of the PSC Program Management teams that provides specialty end-to-end case management services for multiple brands and roles. The individual in this role will focus on helping...
-
Expert Accounting Specialist USA
hace 2 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoNovartis Farmacéutica is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve. We are seeking an Expert Accounting Specialist to join our team in the USA.About the RoleThe Expert Accounting Specialist will provide expert advice to superiors for Financial Reporting &...
-
Senior Accounting Specialist for Financial Reporting
hace 3 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoRole OverviewThis Senior Accounting Specialist will play a key role in supporting the financial reporting and accounting requirements for the general ledger, ensuring timely and accurate compliance with external and internal accounting reporting standards.About the PositionSupport senior management in providing expert advice on financial reporting and...
-
Network Security Specialist
hace 4 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoJob SummaryThe Security Engineering team at Novartis Farmacéutica is seeking a Network Security Engineer to collaborate across multiple regions and work on developing security vendor technologies.About the RoleMajor Accountabilities:Act as a strong IT professional for Check Point technologyCollaborate closely with service lines and architecture to deliver...
-
victoria, México Novartis Farmacéutica A tiempo completoGood Clinical Practices and Pharmacovigilance Sr. Auditor Job ID REQ-10025384 Oct 11, 2024 Mexico Summary Lead, support and report independent GCP/PV audits according to the NVS Quality Sys-tem and the current GCP/PV regulations to assess compliance with applicable regula-tions, standards, and guidance documents. Review and approve corrective...
-
Global Clinical Trial Operations Manager
hace 4 semanas
Cd. Victoria, Tamaulipas, México Novartis Farmacéutica A tiempo completoWe are seeking a skilled Global Clinical Trial Operations Manager to contribute to the delivery of study outcomes within schedule, budget, quality/compliance and performance standards.Key Responsibilities:Assist in the execution of trials & trial related activities for assigned clinical program(s) within budget, and in compliance with quality...
-
Record to Report Specialist
hace 1 mes
victoria, México Novartis Farmacéutica A tiempo completoTo provide expert advice to superiors for Financial Reporting & Accounting and manage the reporting and accounting requirements for the general ledger; to ensure compliance with external and internal accounting reporting requirements in a timely and accurate manner. About the Role Location: Mexico City #Hybrid Your responsibilities include, but are not...
-
SSU Manager
hace 2 meses
victoria, México Novartis Farmacéutica A tiempo completoOur SSU Manager contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May have the opportunity to lead specific aspects of global clinical trial process. Contributes to operational excellence through process improvement and knowledge...
-
Record to Report Sr. Specialist USA
hace 2 meses
victoria, México Novartis Farmacéutica A tiempo completo-To provide expert advice to superiors for Financial Reporting & Accounting and manage the reporting and accounting requirements for the general ledger; to ensure compliance with external and internal accounting reporting requirements in a timely and accurate manner. About the Role Key Responsibilities: Work with direct managers to support financial...
-
Customer Model
hace 4 semanas
victoria, México Novartis Farmacéutica A tiempo completoJob ID: REQ-10026121 Location: Mexico City, #LI-Hybrid Summary Enable our innovative external/customer focus model that shapes our marketing and go-to-market strategies per disease area and HCS archetypes. Shape the path for building and adopting new marketing and go-to-market capabilities to increase engagement and growth. Improve customer experience and...
-
Talent Acquisition Business Partner
hace 3 semanas
victoria, México Novartis Farmacéutica A tiempo completoManage the end to end Talent Acquisition process for Data, Digital and Information Technology (DDIT) areas in the LACan region. Serve as partner and advisor for the People Leaders and Hiring Managers that request Talent Acquisition services. About the Role Key Responsibilities: Ensure the operational conversion of the Talent Acquisition strategic goals...
-
Global Regulatory Affairs Strategist
hace 3 semanas
Cd. Victoria, Tamaulipas, México Healthcare Businesswomen's Association A tiempo completoJob SummaryWe are seeking a skilled Global Regulatory Affairs Strategist to join our team at the Healthcare Businesswomen's Association. As a key member of our organization, you will play a vital role in ensuring compliance with regulatory requirements and maintaining accurate documentation systems.About the RoleThe successful candidate will be responsible...