Regulatory Affairs Associate Consultant

hace 6 meses


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**:

- Preparation, compilation, and coordination of high-quality regulatory submissions for new product launches, product updates, and throughout the product lifecycle.
- Support coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
- Provide regulatory input, review and approval related to change control.
- Support product portfolio through execution of legal document activities as required.
- Preparation and compilation of regulatory documentation for submission
- Develop and manage regulatory action item tables for country-specific requirements.
- Work with client regulatory managers to develop project implementation plans and manage workload planning to ensure on-time completion of projects and tasks.
- Support client regulatory managers in their registration procedure.
- Provision of weekly updates (at a minimum) to relevant client regulatory managers
- Ensure regulatory standards and timelines are met.
- Plan and track the status of ongoing regulatory projects.
- Regulatory action item tables for country-specific requirements and importation/ exportation needs for change in legal entity.
- Ensuring documents for health authority are submission ready.
- Supporting coordination of label change initiation, label reviews and changes in accordance with regional /country review system and procedure.
- Regulatory input, review and approval related to Change Control.

**Education and Experience**:

- 5+ years of relevant experience with BSc in Pharmacy or related health sciences.
- Must have knowledge of regulations for Cosmetics in Andean Markets (Columbia, Ecudor, Peru, etc).
- Language: English is required.
- Portuguese is desirable.
- Strong working knowledge of Microsoft Word, Excel, Power Point
- Good communication and follow-up skills with country regulatory liaisons for clear understanding of country specific needs for registrations, license updates and import/export requirements.

**The Application Process**:
**Who will you be working for?**

**About ClinChoice**:
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.

**Our Company Ethos**:
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.

**#LI-TT1**

**ClinChoice is an Equal Opportunity Employer / Committed to Diversity



  • 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...


  • 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...


  • 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...


  • 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...


  • Bogota, Colombia Takeda Pharmaceutical A tiempo completo

    **Regulatory Affairs Specialist** **_ Versión Español_** **PROPOSITO DEL ROL** Este rol es responsable de apoyar el plan estratégico del negocio para obtener autorizaciones de comercialización y variaciones, tanto para productos existentes como nuevos. Además, coordinará las actividades de Excelencia Regulatoria en Colombia asegurando el...


  • 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...


  • Bogota, Colombia Galderma A tiempo completo

    With a unique legacy in dermatology as well as decades of cutting-edge innovation, Galderma is the pure-play dermatology category leader, present in approximately 90 countries. We deliver an innovative, science-based portfolio of premium flagship brands and services that spans the full spectrum of the fast-growing dermatology market through Injectable...


  • Bogota, Colombia AbbVie A tiempo completo

    **Company Description** - Preparation of state-of-the-art regulatory dossiers, according to product regulatory strategy previously aligned. - T end to look always for a first pass approval from the health authorities. In case any inquire, assure a timely and accurate response as well as look for learning, avoiding same inquiries in future regulatory...


  • Bogota, Colombia ABBVIE A tiempo completo

    Join us at AbbVie, where medicine, aesthetics, and science are powered by some of the brightest minds in the world. We're a dynamic biopharmaceutical company that offers you the resources you need and a global reach that empowers your innovative mindset. From day one, we've known it takes teamwork, passsion, and culture built on diversity and inclusion to...


  • Bogota, Colombia Boston Scientific Corporation A tiempo completo

    **Work mode**:Hybrid**Onsite Location(s)**:Bogota, CO**Additional Locations**: N/A**Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance** - At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most...


  • 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...


  • 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...


  • Bogota, Colombia MSD A tiempo completo

    The proposed functions for the FTE ( Colombia - Ecuador ) are: **Colombia** - Champion promotional/non promotional materials. - Maintenance of Life Cycle Management of the established products and transversal support within the area. - RA Champion of the RADR system - Colombia. - Management of archiving process in Veeva RIM within the established...

  • Sr Reg Affairs Spec

    hace 6 meses


    Bogota, Colombia Thermo Fisher Scientific A tiempo completo

    Job Description 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 responsibilities, leading...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives** We’re a mission-driven leader in medical technology and solutions with a legacy of integrity and innovation. Work with us to incentivize better patient care, and partner across the industry to make healthcare more affordable and accessible. Be a part of a community of experts committed to ensuring quality, affordable...


  • 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...


  • Bogota, Colombia AbbVie A tiempo completo

    **Company Description** Responsible for the design of the regulatory strategy, planning, and compliance management of the Local Regulatory plans (previously aligned with global and region), as well as the maintenance of the business unit portfolio within the local/regional regulatory framework and according to AbbVie policies, to guarantee the availability...


  • Bogota, Colombia EcoLab A tiempo completo

    En ECOLAB, líder mundial en servicios y tecnologías de agua, higiene y energía, estamos en la búsqueda de un Associate Regulatory Specialist II, para la división de Regulatorio en Bogotá. Este recurso será el encargado de la evaluacion de proyectos de incremento de margen, aprobación de proveedores alternos y certificación o registro de productos en...


  • Bogota, Colombia Medtronic A tiempo completo

    **Careers that Change Lives A role in MCRS offers unique experience opportunities, such as being part of a global team, collaborating with business partners throughout the company, visibility to global structures and impacts, and insight to various processes and functions across Medtronic. We believe that when people from different cultures, genders, and...


  • Bogota, Colombia Vantage Specialty Chemicals A tiempo completo

    Vantage is a leading supplier of naturally derived specialty ingredients and formulations that cater to the evolving needs of industrial and consumer markets. Through our chemistries, our customer focus and our global footprint, we are ENABLING TOMORROW’S SOLUTIONS TODAY. As a company on the move, you’ll be working as part of a collaborative team and...