Empleos actuales relacionados con Tbd Regulatory Affairs Associate 3 - Bogota - Icon plc

  • Associate Regulatory Affairs

    hace 3 días

    Bogota, Colombia Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?**: If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Sr Associate Regulatory Affairs

    hace 2 semanas

    Bogota, Colombia Amgen A tiempo completo

    HOW MIGHT YOU DEFY IMAGINATION? If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Latam Regulatory Affairs Leader Medtech

    hace 4 días

    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 Affairs Associate Consultant

    hace 1 semana

    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**: -...

  • Regulatory Affairs Specialist

    hace 1 semana

    Bogota, Colombia MSD A tiempo completo

    **Job Description**: **Objetivo del cargo Regulatory Affairs Specialist Animal Health**: Respaldar al Director Científico en su actuación ante el Instituto Colombiano Agropecuario en Colombia, con el fin de asegurar el cumplimiento de las regulaciones regionales por parte de la operación de la compania en el país. Colaborar en el proceso de registro para...

  • Regulatory Affairs Specialist

    hace 3 días

    Bogota, Colombia Reckitt A tiempo completo

    ¿Quieres llevar tu carrera de Asuntos Regulatorios a otro nível en una multinacional de consumo masivo? como Regulatory Affairs Specialist para la línea de Nutrición podrás tener la libertad de innovar y proponer para asegurar nuestro crecimiento y aterrizar nuestras nuevas ideas. **El objetivo del cargo es**: Manejar el portafolio de productos de...

  • Regulatory Affairs Specialist

    hace 1 semana

    Bogota, Colombia 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...

  • Practicante - Regulatory Affairs

    hace 1 semana

    Bogota, Colombia Genfar A tiempo completo

    **Descripción de la empresa** **_ Elijo Cuidarme, Yo Elijo Genfar_** El lograr una vida plena y saludable es posible. En Genfar, esto se logra a través de su gente; personas con distintas nacionalidades, roles, conocimientos y creencias que luchan constantemente para llevar lo mejor del mundo de la salud, a toda la sociedad con los más altos estándares...

  • Medical Affairs Associate Director Hiv

    hace 3 días

    Bogota, Colombia Gilead Sciences A tiempo completo

    Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. **For Current Gilead Employees and...

  • Medical Affairs Associate Director Hepatitis

    hace 3 días

    Bogota, Colombia Gilead Sciences A tiempo completo

    Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams. **For Current Gilead Employees and...

Tbd Regulatory Affairs Associate 3

hace 2 semanas

Bogota, Colombia Icon plc A tiempo completo

Regulatory Affairs Associate 3

JR093891

Site: Colombia (Bogotá)

At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives.

Our ‘Own It’ culture is driven by four key values that bring us together as individuals and set us apart as an organization: Accountability & Delivery, Collaboration, Partnership and Integrity. We want to be the Clinical Research Organization that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That is our vision. We are driven by it. And we need talented people who share it.

If you’re as driven as we are, join us. You will be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you will be helping shape an industry.

**Responsibilities**:

- Management of activities associated with obtaining initial, amendment and other central authority approvals i.e. Regulatory Agency (RA), Central Independent Ethics Committee (IEC) and any other central authorities for the assigned country/countries.
- Management of central/country level submissions associated with ensuring Investigational Product (IP) and any other clinical trial supplies can be imported and where applicable, exported into/from the country(s) the LRAA is responsible for.
- Ensuring that IP labels are in adherence to country requirements and submitted where applicable.
- Management of the central/country level Informed Consent and any other documentation given to patients i.e. diaries, questionnaires through to submission and approval by country level RA and Central IEC as appropriate.
- Tracking and reporting of central submission/approval progress in Clinical Trials Management System (CTMS), eTMF and other applicable PRA systems.
- Perform role of Local Reviewer in the QC process as appropriate.
- Providing consultancy to the client on any country specifics issues if requested by the Start-Up Lead (SUL), GRAL, Clinical Team Manager (CTM) or Project Manager (PM).
- Supporting the senior level Regulatory staff/Country Consultant in the maintenance of the accurate, up to date Country Knowledge Repository.
- Attending internal and external project team meetings as determined by the GRAL, SUL, CTM or PM.
- Support Business Development opportunities by providing regulatory input on assigned RFPs, RFIs and BDMs, including representing GRA at internal and external BD meetings.
- Contribute to the maintenance and collection of Regulatory Intelligence by ensuring that tools such as the Country Knowledge Repository and the Country Fact Sheets are up to date; communicate new information or changes to the Regulatory Intelligence Consultant team.

Provide mentoring and training for the RAA 1 and RAA 2 position

You will need:
Clinical Research Experience

1, 2 or more years of exp.

Exp. in Microsoft Office

Exp with INVIMA

Exp with ERP

Experience with Clinical Studies

Exp. working in Pharmaceutical Companies, or CRO's

Advanced or Fluent English for reading, writing, and speaking

Degree in Health

To be successful in the role, you will have:
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Benefits of Working in ICON:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

Bu