Director, Global Regulatory Affairs

hace 4 meses


Panamá Provincia de Panamá, Panamá Msd France A tiempo completo

The GRACS Global Process Lead (GPL) is responsible for overseeing and managing Global Regulatory Affairs & Clinical Safety (GRACS) global business processes.
This includes defining and optimizing end-to-end processes and ensuring consistency and standardization across regions and functional areas.The role of the GPL involves developing and maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across GRACS.
The GPL actively engages with leadership across the GRACS organization and collaborates with internal and external functions such as our company's QA, GCD Standards, and Learning & Development.
This collaboration is essential in developing and executing strategies that support the ongoing business needs of GRACS, including training process standards and strategies to ensure optimal quality and compliance in GRACS business processes.Core Responsibilities may include and are not limited to: Establish and maintain an engaged SME network as well as collaborative, and innovative culture in GRACS for business process management and continuous improvement.
Establish and lead assigned domain Global Process Control Boards (GPCBs), accountable for successful design and performance of multiple global business processes ensuring alignment of global to local procedures.Collaborates with various SMEs, including leading cross-functional teams, to drive process improvements, streamline operations, and achieve business objectives on a global scale.Deep domain knowledge of the end-to-end process for their respective global business processes (e.g., enabling systems, upstream and downstream transfer of information and assets).Accountable for ensuring comprehensive and expert input into decisions/changes that affect business processes, roles and responsibilities, and role-based training associated with core business processes.Partner with Business System Owners on Alignment of Process & Technology.Develop &/or and manage process related artifacts (process maps, documentation, training content and role identification), ensuring alignment across impacted functional areas.Drive accountability for processes execution throughout GRACS through change management.
Develop, implement and report process objectives and key performance indicators for assigned global process domains; Manage and report process performance against metric targets.Complete Impact assessment on new or changed external regulatory policies as it pertains to the processes that they own.Lead large-scale change initiatives across GRACS and engage across GRACS leadership to identify GRACS-level projects for continuous improvement of the organization, including managing the impact of final external regulatory policies that support work that is executed in GRACS.Ensure organizational compliance with global regulations including integration of Final Policy requirements into core business processes and procedures.
Conduct process assessments, manage pre-requests, and participate in audits and inspections related to GRACS processes.Develop and improve upon business process management organization capabilities (e.g., lean six sigma, change management, executive-level facilitation, project management, negotiations, etc.
).Ensure alignment with cross-functionally outside of GRACS and throughout the our company to develop and improve enterprise-wide process optimization.Represent our company, GRACS, BCST, Process Management, Metrics and/or Knowledge Management profession in forums outside the department, including participation on M&A or Business Development Execution, as well as engagements outside the companyEducation: Bachelor's degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated environment.Master's Degree and a minimum of 8 years of industry experience including a regulatory and/or compliance area and experience with technical systems in a regulated environment.Required Skills: Demonstrated success in both group-based and executive level facilitationDemonstrated success in leading strong, high performing teamsDemonstrated success in change initiatives across a wide range of project sizes and endpoints including executive-level change initiatives.
To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.#GRACS#EBRG#EligibleERPEmployees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).
Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on



  • Panamá, Provincia de Panamá, Panamá MSD A tiempo completo

    We invite you to join our Team! This position is in charge of the coordination of the product registration process in order to guarantee the approval to market and distribute new products, permissions to market and/or to import products into the various markets we serve. In addition, for ensuring the appropriate filing/documentation related to product...


  • Panamá, Panamá Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Panadol, Advil, Voltaren, Theraflu, Otrivin, and Centrum - through a unique combination of deep...


  • Panamá, Panamá Servier Centroamérica Y Caribe A tiempo completo

    MAIN RESPONSIBILITY The Jr. Regulatory Affairs Coordinator will be responsible for managing and ensuring compliance with local regulations regarding the registration, renewal, and variation of pharmaceutical products. This role is crucial for ensuring that all products meet regulatory requirements and maintaining effective communication with Competent...


  • Panamá, Panamá Novartis A tiempo completo

    **Summary**: - Directs the development of submission of product registration, progress reports, supplements, amendments, and/or periodic experience reports. Provides strategic product direction to teams on interaction and negotiates evidence with regulatory agencies. Interacts and negotiates with regulatory agency personnel in order to expedite approval of...


  • Panamá, Provincia de Panamá, Panamá Organon A tiempo completo

    Job DescriptionDescription of The Position Responsible for all post-marketing surveillance and Regulatory Affairs submission requirements and post-marketing surveillance activities for their assigned product portfolio according to Organon policies and procedures in Central America and Caribbean countries, as applicable.Responsibilities The Specialist is the...


  • Panamá, Panamá Merck A tiempo completo

    Job DescriptionThe Latin American General Medicine Regional Director Medical Affairs is responsible for provide regional input and driving execution of Value and Implementation Plans (excluding pulmonary hypertension). They are impactful members of regional cross-functional teams, including regional Commercial, Center of Real-World Evidence, Policy and...


  • Panamá, Provincia de Panamá, Panamá Organon A tiempo completo

    **Description of The Position** Responsible for all post-marketing surveillance and Regulatory Affairs submission requirements and post-marketing surveillance activities for their assigned product portfolio according to Organon policies and procedures in Central America and Caribbean countries, as applicable. **Responsibilities** The Specialist is the...

  • Director de Proyectos

    hace 6 meses


    Panamá, Panamá SGF Global A tiempo completo

    DIRECTOR DE PROYECTOS Responsable del plan y ejecución proyectos y análisis de los riesgos y amenazas que pueden poner en peligro el éxito del proyecto FUNCIONES: - Administrar todos los aspectos de un proyecto de construcción (presupuesto, programación, calidad) - Desarrollar, administrar y dar seguimiento a la puesta en marcha de los proyectos de...

  • Director, Actuary

    hace 7 meses


    Panamá, Panamá Prudential A tiempo completo

    Job Classification: Actuarial - Actuarial The Annuity Calculation Management team is responsible for all technical aspects of annuity product initiatives and ongoing management of the current annuity product portfolio. This person has accountability for ensuring delivery of these products aligned with actuarial guidelines, SEC and insurance regulations....

  • Regional Director

    hace 7 meses


    Panamá, Panamá UNICEF A tiempo completo

    **Job no**: 572538 **Contract type**: Fixed Term Appointment **Duty Station**: Panama City **Level**: D-2 **Location**: Panama **Categories**: Senior Leadership Vacancies, Executive Management UNICEF works in some of the world’s toughest places, to reach the world’s most disadvantaged children. To save their lives. To defend their rights. To help...

  • Global Category Expert

    hace 3 meses


    Panamá, Provincia de Panamá, Panamá Nestle Operational Services Worldwide SA A tiempo completo

    **Position snapshot** - Location: Panama City, Panama - Company: Nestrade Procurement Division - Act. Rate: Full-Time Act. Rate 100 % - Type of contract: Permanent - Genuine opportunities for career development, training and personal development. - Dynamic international working environment. **Position Summary** We are currently looking for an experienced...


  • Panamá, Panamá Millicom A tiempo completo

    Redactar, negociar y revisar los contratos de la compañía de acuerdo a los procedimientos internos de la empresa y disposiciones legales aplicables. Atender los procesos judiciales, arbitrales, administrativos, penales que se pudieren presentar. Liderar el Asesoramiento en asuntos Regulatorios de la compañía. Coordinar con el área de Seguridad Física...


  • Panamá, Provincia de Panamá, Panamá Adidas A tiempo completo

    Senior Manager Global Distribution Excellence [LAM]- Area: Supply Chain Management Department: Global Distribution Direct Reporting Line: Director Global Distribution Excellence Indirect/Secondary Reporting Line: n/a Subsidiary/Country: LAM Location: Panama (PAN) GSMS Grade: M3 Personnel Managed: No Cost Center/Budget and/or Revenue Responsibility:...


  • Panamá, Panamá Sparx Therapeutics A tiempo completo

    Join the Spark Team We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation. We don’t follow footsteps. We create the path. **Primary Duties** The Senior Medical Science...


  • Panamá, Panamá, Panamá Atsg Corporation A tiempo completo

    At Atsg Corporation, we are seeking a highly skilled Global Anti-Corruption Expert to join our team in Panama City, Panama. As a full-time position, this role will be responsible for enhancing our partnership with the U.S. Department of State (DOS) Bureau of International Narcotics and Law Enforcement Affairs' (INL) on the Central America Regional Security...


  • Panamá, Panamá Pfizer A tiempo completo

    **MAIN REPONSIBILITIES / DUTIESMEDICAL**: -Ensures that category medical team provides support and the necessary medical and scientific information of Pfizer Biopharmaceutical Group products to internal and external customers assuring compliance with Corporate and Local Procedures and applicable regulations providing full support to our local medical...

  • Panama Scmoq Officer

    hace 3 meses


    Panamá, Provincia de Panamá, Panamá Pfizer A tiempo completo

    JOB FOCUS The key role of the SCMOQ Officer is to support Panama SCMOQ Manager on establishing and maintaining an appropriate and sustainable Product Quality System and Quality Culture at Logistic Service Provider (LSP) and Panama Pfizer Country Office (PCO) in order to ensure compliance with Pfizer and Regulatory Authority expectations. Provides support...


  • Panamá, Panamá, Panamá ATSG Corporation A tiempo completo

    Administrative Assistant (Transnational Threats and Crime)ATSG Corporation is a service-disabled veteran-owned small business that provides technical solutions to various Federal agencies.We are seeking an experienced Administrative Assistant to support our team in Panama City, Panama. The selected candidate will work closely with the U.S. Department of...


  • Panamá, Panamá VF Corporation A tiempo completo

    **Job Overview**: The Director of Global Product Supply Planning will be responsible for developing and executing the planning strategics, overseeing and optimizing the global product supply planning operations focusing on capacity planning and utilization, production planning and follow up. This role will inspire and lead a team of 40 associates across...

  • Marketing Director

    hace 2 meses


    Panamá, Provincia de Panamá, Panamá Millicom A tiempo completo

    Would you like to help us achieve our purpose of connecting more people, improve their lives and develop our communities? If so, Tigo is for you! We believe in innovation, we adapt and are agents of change. Our customers are at the center of everything we do. Come and grow with our team, where together we will transform lives and communities. Additionally,...