Regulatory Affairs Operations Analyst

hace 4 meses

Bogotá Cundinamarca, Colombia 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, Dolex, Coega, Today and Centrum - through a unique combination of deep human understanding and trusted science. What’s more, we’re achieving it in a company that we’re in control of. In an environment that we’re co-creating and a culture that’s uniquely ours. Care to join us.

The Regulatory Operations Analyst - LATAM provides operational support for compliance activities within LATAM, including documentation management, training, audit support, and CAPA follow-up when needed. This role ensures regulatory risks are identified and mitigated, supports LATAM systems like VEEVA, and collaborates on regional regulatory submission activities. The analyst works closely with local regulatory teams to address regulatory matters and contributes to the development and execution of global and regional compliance, innovation & maintenance strategies.

Key Responsibilities
- Support portfolio CMC documentation creation for regulatory submissions and the applicable compliance management within the LATAM Regulatory Affairs (EMEA/LATAM, if required) organization, ensuring adherence to global, regional, and local processes, policies, SOPs, and working instructions.
- Support best practices for Regulatory Affairs processes and optimization during the implementation of new systems or regulatory activities Connected with the change control process.
- Provide solutions to complex problems requiring data analysis and evaluation of intangible variables, including support for portfolio CMC maintenance, VEEVA, etc.
- Collaborate on process improvements and issue resolution for compliance issues, helping to review and enhance existing processes.

Why you?

Basic Qualifications:
We are looking for professionals with these required skills to achieve our goals:

- Bachelor’s degree in Pharmacy, Chemical Engineering or related fields.
- 2 years of experience in Regulatory Affairs, CMC or Quality documentation in FMCG or pharma industries.
- Advanced level of English.

Diversity, Equity and Inclusion

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone.

We’re striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

At Haleon we embrace our diverse workforce by creating an inclusive environment that celebrates our unique perspectives, generates curiosity to create unmatched understanding of each other, and promotes fair and equitable outcomes for everyone. We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives. We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.

Haleon is an Equal Opportunity Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure Haleon’s compliance to all federal and state US Transparency requirements.

  • Regulatory Affairs Coordinator Latam

    hace 1 mes

    Bogotá, Cundinamarca, Colombia Galderma A tiempo completo

    Con un legado único en dermatología y décadas de innovación de vanguardia, Galderma es el líder emergente en la categoría de dermatología, presente en aproximadamente 90 países. Ofrecemos un portafolio innovador basado en la ciencia de marcas emblemáticas premium y servicios que abarcan todo el espectro del mercado de la dermatología en rápido...

  • Regulatory Affairs Specialist

    hace 2 meses

    Bogotá, Cundinamarca, Colombia Solventum A tiempo completo

    Job Description: Regulatory Affairs Specialist, Colombia (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health,...

  • Regulatory Affairs Project Coordinator

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Bostonscientific A tiempo completo

    Job SummaryWe are seeking a highly motivated and detail-oriented Regulatory Intern to join our team at Boston Scientific. This is an exciting opportunity to gain hands-on experience in regulatory affairs and contribute to the development of innovative medical solutions.About UsBoston Scientific is a global leader in medical science, committed to solving the...

  • Senior Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Colombia Buscojobs Colombia A tiempo completo

    Regulatory Affairs Coordinator Latam - Distributor Markets Location: Bogotá Core Mission: Implement Regulatory Affairs programs, processes and policies to support regulatory activities related to products in the Latin American distributor markets. Job Responsibilities: Participate in the planning of Regulatory strategies for product submissions. ...

  • Dermatology Regulatory Affairs Professional

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Galderma A tiempo completo

    Galderma, a pioneering dermatology company with a unique legacy and decades of innovation, is the emerging leader in its category, present in approximately 90 countries. Our innovative portfolio is based on premium brand science and services that cover the growing dermatology market through Injectable Esthetics, Dermatological Care, and Therapeutic...

  • Regulatory Affairs Specialist

    hace 2 meses

    Bogotá, Cundinamarca, Colombia CooperVision A tiempo completo

    Carrying out, controlling, and implementing activities related to the company's quality system. Carrying out, controlling, and implementing the regulatory processes applicable to the company's activities and products. Providing support to the RAQA manager in the department's activities. CooperVision is a global leader in the contact lens industry, dedicated...

  • Senior Specialist Regulatory Affairs Latam Andean

    hace 4 semanas

    Bogotá, Cundinamarca, Colombia International Flavors & Fragrances A tiempo completo

    Job Summary Senior Regulatory Affairs Specialist. Focused in Product Compliance and advocacy, business and customer support. Accountable to execute regulatory strategy in the Andean Region. Main focal point to the Functional Ingredients Business. Good relationship skills, good food regulatory knowledge (Andean). Participation in Trade Associations....

  • Regulatory Affairs Coordinator: Strategic Product Submissions

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

    **Job Title:** Regulatory Affairs Coordinator: Strategic Product SubmissionsAbout the Role:We are seeking a highly skilled Regulatory Affairs Coordinator to join our team at Pfizer. As a key member of our regulatory department, you will play a crucial role in ensuring compliance with local regulations and facilitating business continuity.Responsibilities:You...

  • Regulatory Affairs Coordinator Latam

    hace 3 semanas

    Bogotá, Colombia Galderma A tiempo completo

    Con un legado único en dermatología y décadas de innovación de vanguardia, Galderma es el líder emergente en la categoría de dermatología, presente en aproximadamente 90 países. Ofrecemos un portafolio innovador basado en la ciencia de marcas emblemáticas premium y servicios que abarcan todo el espectro del mercado de la dermatología en rápido...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Bogotá, Colombia Solventum A tiempo completo

    **Regulatory Affairs Specialist, Colombia (Solventum)** **3M Health Care is now Solventum** At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material...

  • Regulatory Affairs Coordinator Expert

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Pfizer A tiempo completo

    Pfizer seeks a skilled Regulatory Affairs Coordinator to join our team. This is a full-time opportunity based in Colombia - Bogota - Suba.The estimated salary for this position is $60,000 - $80,000 per annum, depending on experience and qualifications.About the RoleWe are looking for a highly motivated and detail-oriented individual to coordinate and execute...

  • Regulatory Affairs Specialist

    hace 2 meses

    Bogotá, Cundinamarca, Colombia AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...

  • Regulatory Affairs Coordinator

    hace 4 meses

    Bogotá, Cundinamarca, Colombia Convatec A tiempo completo

    **What will you do?** - Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings. - Provides direction regarding the quality requirements of Convatec 's new and marketed products, as well as helping support the implementation of long term companywide quality strategies and operating...

  • IT Inhouse Consultant Regulatory Affairs

    hace 2 meses

    Bogotá, Cundinamarca, Colombia B. Braun Business Services S.A.S. A tiempo completo

    **Company description**: TRABAJAMOS CADA DÍA PARA SER UN PROVEEDOR COMPLETO PARA EL CUIDADO DE LA SALUD. En B. Braun desarrollamos soluciones eficientes y buenas prácticas para el cuidado de la salud gracias a un diálogo constructivo con nuestros clientes y colaboradores. A través de una estrecha relación y cooperación con los profesionales de la salud...

  • Senior Director of Medical Affairs

    hace 4 semanas

    Bogotá, Colombia Novo Nordisk A tiempo completo

    Senior Director of Medical Affairs & Regulatory Affairs **Category**:Clinical Development **Location**:Bogota, Cundinamarca, CO **The Position** - As Senior Director of Medical Affairs and Regulatory Affairs at Novo Nordisk, you will provide strategic leadership and ensure the alignment of medical and regulatory strategies with the organization’s goals....

  • Regulatory Affairs Senior Manager

    hace 2 meses

    Bogotá, Cundinamarca, Colombia DSM A tiempo completo

    **Job Title: Regulatory Affairs Senior Manager (Colombia / Bogotá)** **City: Colombia / Bogotá** **Work Model**:Hybrid** **Clevel: C42** As Regulatory Affairs Senior Manager, you will be responsible for to support the DSM-Firmenich Taste Texture and Health (TTH) business in Andean Region for the Ingredients Solutions (50%) and Pet Food (50%) segments....

  • Regulatory Affairs Specialist

    hace 1 mes

    Bogotá, Bogotá D.E., Colombia Stryker Group A tiempo completo

    **Job Summary:**We are seeking an experienced Regulatory Affairs Specialist to join our Stryker Group team in LATAM. The successful candidate will be responsible for executing regulatory affairs activities, collecting and maintaining files on RAQA intelligence, and identifying the need for new regulatory procedures.**Key Responsibilities:**

  • Regulatory Affairs Coordinator

    hace 3 semanas

    Bogotá, Colombia Pfizer A tiempo completo

    Regulatory Affairs Coordinator Location: Colombia - Bogota - Suba Time Type: Full-time Posted: 3 days ago JOB RESPONSIBILITIES: Participate in the planning of Regulatory strategies for product submissions and lifecycle, including APIs related to products under her/his responsibility. Coordinate and execute activities related to: Dossier...

  • Regulatory Affairs Specialist for Latin America

    hace 2 semanas

    Bogotá, Bogotá D.E., Colombia Galderma Pharma S.A A tiempo completo

    Galderma Pharma S.A. offers a competitive salary of $80,000 to $100,000 per year in Bogotá, Colombia.About the JobWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Latam. As a key member of our regulatory team, you will be responsible for implementing regulatory affairs programs and processes to support our activities in...

  • Senior Regulatory Affairs Professional

    hace 3 semanas

    Bogotá, Bogotá D.E., Colombia Stryker Corporation A tiempo completo

    Stryker Corporation Job OpportunityWe are seeking a Senior Regulatory Affairs Specialist to join our team in Bogota D.C., Colombia.Estimated Salary: $60,000 - $80,000 per annum.About the RoleThis is a full-time position with hybrid work flexibility.The ideal candidate will have 4+ years of experience in regulatory affairs and a strong understanding of...