Regulatory, Quality

hace 4 semanas

Bogota, Colombia CSL Behring A tiempo completo

**The Opportunity**:
Reporting to the General Manager of our Colombia affiliate, as the Regulatory, Quality & PV Manager, you will be responsible for Regulatory Affairs, Quality Assurance, and Pharmacovigilance, including the supervision of third party providers in those areas and report to functional departments the relevant information.

**_ As Regulatory Affairs Responsible 70%:_**
- The Regulatory Affairs Responsible is in charge to register and maintain the marketing authorization up-to-date to ensure the supply of CSL products in compliance according to the applicable regulation in Colombia and CSL policies and SOPs.

**_ As Quality Responsible (LQO) 15%: (Technical Director):_**
- The LQO is the responsible party in the establishment and maintenance of local, affiliates and global quality procedures. It is also responsible for training all internal and external personnel (where necessary) performing GxP activities on behalf of CSL Behring.
- In addition, you will be responsible for the assessment and timely completion of product deviations, Product Technical Complaints, CAPAs, Change Control, Product Recalls and Product Counterfeit investigations. Coordinates the submission of finished product samples to the testing laboratory and review and approves the test results.
- The LQO supports regulatory inspections of the affiliate and collaborates with Customer Service, Medical Information and Global Logistics to resolve customer inquiries relevant to product quality and possible temperature/storage concerns according to local legislation.
- You will be responsible to supervise the third party service provider that test the products in order to release them into the market. Is the legal responsible for the quality of the products in front of local authorities giving them her/his own signature guarantee.

**_ As Pharmacovigilance responsible ( LSO) 15%:_**
- The LSO is the legal responsible person for Competent Regulatory Authority in the establishment and maintenance of the local PV system, which includes Pharmacovigilance for all CSLB products licensed, marketed or supplied within the territory, compliance with international regulations (e.g.GVP), inspection readiness/support, pharmacovigilance procedural documentation development and maintenance of local information relevant for the Pharmacovigilance System Master File.
- The LSO ensures ICSR Handling, submission of expedited ADR reports, aggregate safety reports and safety signals as required to local competent regulatory authorities in accordance with the applicable regulatory requirements ensuring business continuity plan exists, unless expedited reporting is directly performed by a CSL PV site.

**The Role**:
**_ Regulatory Affairs_**
- Collect, translate and present the necessary information to local authorities in order to obtain registration of products.
- Responsible for the collection, validation and internal communication of local requirements
- Regular reporting to senior management and peers to ensure alignment of strategic planning.
- Coordinate labelling implementation between sites, markets and Supply Chain to ensure that the products can be imported
- Coordination of activities required to ensure that only compliant products (i.e., matching the approved regulatory status) are supplied (close collaboration with Intercontinental Supply Chain), especially for labeling changes.
- Responsible for the communication with the local Authorities

**_ Quality Responsible (LQO)_**
- Manages Quality Assurance SOPs compliance in order to release the products after
- Importation and before going to the market. Is responsible to trace products and organize and implement product recall whenever needed. Assess and train specific personnel in new products. Is the legal responsible for the quality of the products in front of local authorities giving them his own signature guarantee. Drive continuous improvement and efficiency initiatives in Quality Operations

**_ Quality Compliance_**
- Serves as the Local Quality Officer for the CSL Behring Colombia Affiliate. Ensures compliance with all CSL Behring requirements for the affiliate operations in Colombia and CSL Behring global SOPs, policies and local regulatory requirements.
- Creates and maintains (when required) local quality SOPs according to the CSL Behring global quality policies and local regulatory requirements. Ensures that the local procedures are compliant with the Country specific regulations and that the Affiliate is compliant in its implementation. Contribute to Global Quality procedures when requested.
- Ensures accurate, reliable recording, storage, archiving system for all GxP related documents.
- Maintains the affiliate ready for local regulatory inspections

**_ GxP and Pharmacovigilance (PV)Training_**
- Establishes and maintains a GxP training program in the Colombia Affiliate for functions requiring GxP training documentation including personal training records.
- Serves as the GxP and

  • Regulatory Affairs Manager

    hace 4 días

    Bogota, Colombia Lilly A tiempo completo

    At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our...

  • Senior Regulatory Affairs Specialist

    hace 3 semanas

    Bogota, Colombia Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office We are currently seeking a Senior Regulatory Affairs Specialist to join our global Regulatory Affairs department. This is a fantastic opportunity to further develop your regulatory career and expertise in a global clinical trial setting. In this role you will be a pivotal team member with...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER28216 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: Responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission...

  • Intern Regulatory Affairs

    hace 2 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    **Requisition Number**: AMER29097 **Employment Type**: Full-time **Location**: Bogota **Job Summary**: The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities...

  • Intern Regulatory Affairs

    hace 2 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    -Requisition Number AMER29097 Employment Type Full-time Location Bogota **Job Summary**: - The Regulatory Affairs Department of ZB plays a critical role in ensuring that our products comply with all regulations and requirements established by regulatory authorities. This department is responsible for coordinating and managing all activities related to the...

  • Regulatory Affairs Specialist

    hace 4 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds. As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life...

  • Regulatory Affairs Specialist, Latam

    hace 6 días

    Bogota, Colombia Novasyte A tiempo completo

    POSITION TITLE: Regulatory Affairs Specialist REPORTS TO: Manager, Regulatory Affairs or Designee BASIC FUNCTIONS: ESSENTIAL JOB FUNCTIONS, DUTIES AND RESPONSIBILITIES: - Assist Manager, Regulatory Affairs, in assuming primary or secondary regulatory responsibility for assigned clinical research projects by providing regulatory information, guidance,...

  • Quality Systems Specialist

    hace 3 semanas

    Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives **A Day in the Life**: - Execution of Complaint Handling activities: Regulatory decisions and regulatory reporting (drafting and submission). - Execute tasks using Complaint Handling tools/systems (Global Complaint Handling system). - Ensure closure of regulatory reports with investigation are done timely, consistently and in...

  • Quality and Regulatory Compliance Specialist Av

    hace 1 mes

    Bogota, Colombia Abbott Laboratories A tiempo completo

    **_MAIN PURPOSE OF ROLE_** Individual contributor that works under limited supervision. **_ MAIN RESPONSIBILITIES_** - 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...

  • Regulatory Affairs Specialist

    hace 5 días

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson Vision, a member of Johnson and Johnson's Family of Companies, is recruiting for a Regulatory Affairs Specialist located preferably in Colombia, or Mexico. An exciting opportunity to join a diverse team. At Johnson & Johnson Vision, we have a bold ambition: to change the trajectory of eye health. That’s why, through our operating...

  • Specialist, Regulatory, Shared Service Delivery

    hace 2 días

    Bogota, Colombia MSD A tiempo completo

    The SSDM Regulatory Coordinator supports the SSDM Associate Director and will partner with the functional areas and Country Regulatory Affairs to ensure the regulatory post-approval operations in scope of SSDM (i.e.: Renewals, Deletions, Mergers, Acquisitions, Transfers, Legal Entities changes, Site name changes, Tender Bids, labeling activities and artwork...

  • Regulatory Affairs Associate Consultant

    hace 2 semanas

    Bogota, Colombia ClinChoice A tiempo completo

    Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it's the best of both worlds. ClinChoice is searching for a Regulatory Affairs Associate Consultant to join one of our clients. **Main Job Tasks and Responsibilities**: -...

  • Senior Quality Associate

    hace 2 semanas

    Bogota, Colombia Ortho Clinical Diagnostics A tiempo completo

    **The Opportunity**: QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers...

  • Latam Regulatory Affairs Leader Medtech

    hace 2 meses

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is one of three successful divisions of the world's leading Johnson & Johnson family of companies. We are making an important contribution to the successful treatment of a wide range of common and chronic diseases with innovative - often pioneering - medical technologies and products. Are you ready to take your regulatory affairs...

  • Regulatory Administrator, Bogota

    hace 4 semanas

    Bogota, Colombia Carbon Health A tiempo completo

    As a physician-founded and led organization, ensuring everyone has access to quality healthcare is what inspires us. That’s why we hire people who genuinely care about patients, solving healthcare challenges, and making a positive impact every day. Join us and help change the future of healthcare for the better. - 120+ locations and growing, along with...

  • Regulatory Administrator, Bogota

    hace 4 semanas

    Bogota, Colombia Carbon Health A tiempo completo

    As a physician-founded and led organization, ensuring everyone has access to quality healthcare is what inspires us. That’s why we hire people who genuinely care about patients, solving healthcare challenges, and making a positive impact every day. Join us and help change the future of healthcare for the better. - 120+ locations and growing, along with...

  • Clinical Operation Manager

    hace 1 semana

    Bogota, Colombia MSD A tiempo completo

    This role is accountable for performance and compliance for assigned protocols in a country in compliance with ICH/GCP and country regulations, Company policies and procedures, quality standards and adverse event reporting requirements internally and externally. Under the oversight of the Sr. COM, Head COMs or CRD, the person is responsible for...

  • Quality Technician Iii

    hace 2 días

    Bogota, Colombia Jabil Circuit A tiempo completo

    At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design...

  • Commercial Quality Specialist

    hace 2 meses

    Bogota, Colombia Johnson & Johnson A tiempo completo

    Johnson & Johnson MedTech is recruiting for a(n) COMMERCIAL QUALITY SPECIALIST, located in Bogotá Colombia. Responsible for supporting end-to-end quality operations within the North Cluster, ensuring compliance with J&J policies and procedures outlined within the applicable quality management system at Johnson & Johnson. Establishing/maintaining quality...

  • Quality Engineer

    hace 2 semanas

    Bogota, Colombia Zimmer Biomet A tiempo completo

    -Requisition Number AMER27804 Employment Type Full-time Location Bogota **Job Summary**: - Responsible for assuring products conform to established requirements and standards through appropriate audit, inspection, and test activities. Interacts with many different functional departments, suppliers, and experts outside Zimmer Biomet to implement Zimmer...