Director, Global Regulatory Affairs

hace 5 días


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, Panamá Johnson & Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • Panamá, Panamá Johnson And Johnson A tiempo completo

    At Johnson & Johnson, the largest healthcare company in the world, we come together for one purpose: to transform the history of health in humanity. Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130...


  • 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 Johnson & Johnson A tiempo completo

    DE&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...


  • Panamá, Panamá Johnson And Johnson A tiempo completo

    At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across...


  • 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, 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, 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...


  • Provincia de Chiriquí, Panamá Dell Technologies A tiempo completo

    Regulatory Audit Senior AdvisorWe're a global business - a multi-billion-dollar corporation. To stay strong and secure, it’s vital to have robust audit and risk assessment of our processes. That’s where our Internal Audit professionals come in. Preparing independent audit plans, conducting internal reviews and establishing audit criteria, validating...

  • Medical Director, Caricam

    hace 2 semanas


    Panamá, Panamá GSK A tiempo completo

    **Site Name**: Panama - Panama's Capital - Ciudad de Panama **Posted Date**: Jan 14 2025 **Objective of the Role**: Are you looking for a role where you can be the single point of leadership, governance and medical execution accountability for all relevant Pharma and Vaccines activities in the Medical department? If so, this is the role for you. As Medical...

  • Director, Actuary

    hace 1 semana


    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 4 días


    Panamá, Panamá UNICEF A tiempo completo

    **Job no**: 548656 **Contract type**: Fixed Term Appointment **Duty Station**: Panama City **Level**: D-2 **Location**: Panama **Categories**: Senior Leadership Vacancies 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 them fulfill their...


  • Panamá, Panamá Salve.Inno Consulting A tiempo completo

    We are on the lookout for a strategic and results-driven Regional Managing Director to lead operational and business development initiatives within our specified regions. This pivotal role is an opportunity for a seasoned professional to drive growth, foster strategic partnerships, and ensure alignment with the overall vision and objectives of the...


  • Panamá, Panamá Salve.Inno Consulting A tiempo completo

    Bringing a personalized approach to connecting exceptional talent with unique opportunities. Specializing in recruitment for diverse roles, leveraging extensive experience and innovative strategies to find the perfect match for any business needs. Collaboration builds a stronger, more successful future - one strategic hire at a time. We are on the lookout...

  • Global Category Expert

    hace 3 semanas


    Panamá, Panamá Nestlé 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, Provincia de Panamá, Panamá Msd France A tiempo completo

    **Position Description**: Senior Specialist, Standards & ExecutionThe Senior Specialist, Global Regulatory Affairs and Clinical Safety (GRACS) Standards & Execution is a member of Business Continuity, Standards & Training (BCST). This role is critical to the success of the GRACS end to end business process operating model.Under the guidance of the Director,...

  • Finance Director, Latam

    hace 1 semana


    Panamá, Panamá Pandora Jewelry A tiempo completo

    **Finance Director, Pandora LATAM** At Pandora, we give a voice to millions of people’s loves every day through our beautiful products that empower self-expression. We are proud to be part of the most important moments in our customers' lives. Where original thinking is welcomed and can create a positive impact quickly, we dream big, dare to act, and...


  • Panamá, Panamá Nestlé A tiempo completo

    **Position snapshot** - Location: Panama City - Company: Nestrade Procurement Division - Act. Rate: Full-Time Act. Rate 100 % - Type of contract: Permanent - Dynamic, international working environment. - Genuine opportunities for career development, training and personal development. **Position summary** We are seeking an expert in collagens to step into...


  • Panamá, Panamá Maxell Latin America A tiempo completo

    En Maxell, estamos en búsqueda de un talentoso y experimentado Director Comercial E-Commerce para unirse a nuestro equipo en Panamá, Panamá, Panama. En esta posición, serás responsable de liderar y desarrollar estrategias comerciales para impulsar nuestras operaciones de comercio electrónico.Como Director Comercial E-Commerce, tu principal objetivo...


  • Panamá, Panamá Novartis A tiempo completo

    21,000. That’s how many people Novartis hires globally every year. We want curious, courageous and collaborative people like you to join our inspiring environment. Here you’re given opportunities to make a genuine impact on our patient driven mission. Here you’re surrounded by people who share your determination to tackle the world’s toughest medical...