Regulatory Affairs Associate

hace 3 meses


Desde casa, Colombia Parexel A tiempo completo

Colombia, Remote

**Job ID** R0000002443

**Category** Regulatory / Consulting

**ABOUT THIS ROLE**:
An Associate must have a knowledge of the organization´s basic consulting models and methodologies as well as basic knowledge of what services the department provides. An Associate must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and Supervisor, taking responsibility for ensuring that client work is performed and delivered on time, meeting the quality expectations based on Processes of the department and client preferences.

**The publisher**

The publisher assists in the production of submissions and delivery of regulatory services in accordance with defined agency guidelines (ICH) while balancing the quality and timeliness of customer deliverables. A Publisher must be technically competent and continually developing the skills as defined in the responsibilities section of this document. Publisher, under the general direction of a Line Manager and Supervisor takes responsibility for ensuring that client work is performed, and delivered on time, meeting the quality expectations of the department and the client. The guidance of more senior staff may be needed to accomplish more complex tasks.

**Essential Function**

The Publisher of the Lifecycle team is responsible for the following items during her/his shift:

- Works effectively within a team environment, reporting to his/her LM and Supervisor.
- Works within broad project guidelines as directed by Line Manager.
- With the guidance of the Supervisor and Manager, demonstrates the ability to prioritize work to achieve specified project outcomes.
- Under supervision provides electronic publishing services, including preparation of submission packages, bookmarking, hyperlinking, compilation among others.
- Under supervisor performs basic document management task including file transfer, storage, tracking and archival.
- Capitalizes on opportunities to improve one´s own performance and seeks feedback from Manager,
- Supervisor, and colleagues. Applies information provided by Manager or supervisor to complete assigned project activities.
- Produces quality work that meets the expectations of the department based on process and client needs.
- May serve as client facing role for publishing submissions.
- Identify and escalate issues to upper management for a quick resolution based on process and client needs.
- Ensures that the tasks received are done with quality.
- Work and prepare in trainings of New Regulations that will help to the global team.
- Prepares planners, forms, and covers for specific projects.
- Understands ICH Regulations and Health Authorities regulations that impact in his / her daily work.

**Skills**:

- Autonomy and proactivity organized knowing how to prioritize and plan.
- Interpersonal communication.
- Client focus, results orientated,
- Flexibility to work in different scenario.

**Minimum** Work Experience**:

- Initial years of experience in an industry-related environment.
- Preference Regulatory knowledge, ICH Guidance.

**Education**:

- Scientific (Pharmaceutical, Biochemistry, Biotechnology, others) or Technical Discipline (Translator, IT)

**Languag**e** Skills**:

- Fluent verbal and written English.

LI-REMOTE



  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    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 discussions, and...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    We are currently seeking a 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 discussions, and coordinating...


  • Desde casa, Colombia Parexel A tiempo completo

    **Accountability / Scope** - As the professional in the Regulatory Affairs function, the individual will assist teams in the registration of products by preparing documentation needed for registration. - Individual shall develop partnership with other regulatory functions, affiliates & other stakeholder to define plan & strategy for submissions and any...


  • Desde casa, Colombia IQVIA 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...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Sr Reg Affairs Spec

    hace 4 meses


    Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...

  • Sr Reg Affairs Spec

    hace 4 meses


    Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    **Work Schedule** Other **Environmental Conditions** Office At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve...


  • Desde casa, Colombia ICON A tiempo completo

    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 fulfill our mission to advance and improve patients' lives. ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research by providing...

  • Va Legal Assistant

    hace 4 meses


    Desde casa, Colombia Rob Levine Law A tiempo completo

    Rob Levine & Associates is seeking a full-time Legal Assistant to join its growing VA disability team. A VA Legal Assistant plays a crucial role as the experienced administrative support staff to the VA Attorney or Agent in their respective pod. **Compensation**: 3,000,000 COP **Responsibilities**: - Assisting attorneys with intake evaluation, including...


  • Desde casa, Colombia Parexel A tiempo completo

    Everything we do has the potential to impact patient lives, and our Clinical Research Associates (CRAs) take their work seriously, demonstrate empathy, and act with heart. They also perform with urgency, navigating our streamlined clinical operating model to drive effectiveness, reduce handoffs and increase employee, client and site satisfaction. As a CRA...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    We are looking for a Research Associate III (Senior Health Economist - HEOR) to implement simulation models (e.g., discrete event simulation) and other decision-analytic models (e.g., Markov, individual state-transition, survival partition) to assess the cost-effectiveness of healthcare interventions. Manage multiple projects with tasks varying to degree by...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    We are looking for a Research Associate III (Senior Health Economist - HEOR) to implement simulation models (e.g., discrete event simulation) and other decision-analytic models (e.g., Markov, individual state-transition, survival partition) to assess the cost-effectiveness of healthcare interventions. Manage multiple projects with tasks varying to degree by...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through...


  • Desde casa, Colombia Parexel A tiempo completo

    **We are looking for passionate professionals with experience as CRA in Vaccines Studies, to work in Peru and cover cross-boarding onsite monitoring visits in Central America**. **Your time here** At Parexel, the CRA role offers the opportunity to go beyond the role of a typical clinical monitor. CRA’s are accountable for using their expertise to build...


  • Desde casa, Colombia RWS Group A tiempo completo

    Job Purpose: As an Associate Project Planner for Linguistic Validation, your primary mission is to ensure the seamless coordination of translation projects, from initial client inquiries to final delivery. Under the guidance of the LV Project Planning Manager, your focus will be on providing accurate quotes, processing jobs efficiently, and maintaining clear...


  • Desde casa, Colombia RWS Group A tiempo completo

    Job Purpose: The Associate LV Project Manager works closely with the team leader and collaborates with various departments. He/she coordinates the creation of error-free, linguistically validated translations through a reiterative process of harmonization, back translation, expert review, in-country review, and cognitive debriefing. The role communicates...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    **Location/Specific Division**: Cali, Colombia. **How will you impact your position (Objective)**: Develop and implement the strategies given by the management, for the growth of the assigned area, promoting, negotiating, and acting as a factor of change in the different customers through TMF's solutions. Driving the sales of solutions that are in line...


  • Desde casa, Colombia Formula.Monks A tiempo completo

    **Position Overview**: **Responsibilities**: Develop and maintain security control policies and procedures for cloud environments, ensuring alignment with industry standards, regulatory requirements, and organizational objectives. Collaborate with stakeholders to understand business requirements and translate them into actionable security controls and...


  • Desde casa, Colombia Thermo Fisher Scientific A tiempo completo

    At PPD, a Division of Thermo Fisher Scientific, our mission is to improve health. It starts as an idea to find a cure. It becomes a life saved. All in-between, it’s you! We know that meaningful results not only require the right approach, but also the right people. We invite you to re-imagine health promoting protocols with us, working alongside our...

  • Field Auditor Wfg

    hace 3 meses


    Desde casa, Colombia Transamerica A tiempo completo

    Job Family Regulatory Compliance - About Us At Transamerica, hard work, innovative thinking, and personal accountability are qualities we honor and reward. We understand the potential unleashed by leveraging the talents of a diverse workforce. We embrace an environment where employees enjoy a balance between their careers, families, communities, and...