Senior Regulatory Affairs Specialist

hace 7 meses


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 coordinating regulatory strategies globally on assigned (Phase 1 to 4) clinical trials, studies and projects.

You will be part of a global team providing innovative solutions and global regulatory expertise, being client interfacing to provide strategic regulatory intelligence and guidance.

You will feel confident providing regulatory advice and carry out projects in the provision of regulatory affairs services whilst acting as liaison with internal and external clients.

You will act as a representative of the regulatory department with other departments, supporting business development, working on initiatives, and contributing to quality improvement. You will also arrange, lead, and report on client and regulatory agency meetings.

The following skills are required to be successful in this position:

- preparation and assembly of global regulatory submissions
- interacting with sponsors,
- review and assess clinical trial regulatory documents,
- review and assess scientific literature.
- manages project teams and preparation
- participate in launch meetings, review meetings and project team meetings.

Optional skills:

- Experience with bid defense meetings

**Qualifications - External**

What the role requires you to have:

- Bachelor's degree or advanced degree preferred, or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job
- Knowledge of the global clinical trials landscape

Knowledge, Skills and Abilities:

- Excellent command of the English language (written and oral) as well as local language where applicable
- Excellent attention to detail and quality as well as excellent editorial/proofreading skills
- Exceptional interpersonal skills to work effectively in a team environment and act as a liaison with other departments
- Advanced computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologies
- Strong organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projects
- Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
- Excellent understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization; expert knowledge of ICH and other global regulatory guidelines
- Excellent analytical, investigative and problem-solving skills



  • 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

    **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...

  • Sr Reg Affairs Spec

    hace 7 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 7 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 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...


  • Desde casa, Colombia Parexel A tiempo completo

    As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter - and keeping them there -your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical...


  • Desde casa, Colombia IQVIA A tiempo completo

    **Join our team as a Global Regulatory & Start-Up Specialist 1!**: **Job Overview** Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance...


  • Desde casa, Colombia IQVIA A tiempo completo

    **RSU Specialist for External Commerce (ComEx)** **Essential Functions** - Responsible for importations and exportation activities in Colombia for our FSP model - Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines. - Perform start up and site activation activities...

  • Senior IT Specialist

    hace 7 meses


    Desde casa, Colombia Roads Consulting A tiempo completo

    **Position Name**:Senior IT Specialist We are a dynamic and rapidly growing company seeking an experienced Senior IT Specialist to join our talented team of consultants. We pride ourselves on delivering innovative solutions to our clients. We value collaboration, expertise, and a strong commitment to customer satisfaction. **Job purpose** As a Senior IT...


  • Desde casa, Colombia Intellias A tiempo completo

    Project Overview: The customer provides access to technology to improve safety, convenience, and legitimacy while adhering to the strictest degrees of compliance to increase transparency and traceability for all regulatory and governmental bodies. We offer innovative lending solutions built directly into the payments platform. Our technology enables...


  • Desde casa, Colombia EPAM Systems A tiempo completo

    EPAM is a leading global provider of digital platform engineering and development services. We are committed to having a positive impact on our customers, our employees, and our communities. We embrace a dynamic and inclusive culture. Here you will collaborate with multi-national teams, contribute to a myriad of innovative projects that deliver the most...


  • 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 IQVIA A tiempo completo

    **Help create a healthier world**:START RIGHT HERE AT IQVIA.**: **Proficiency in English, both verbally and written are necessary.**: **Please submit resume in English.**: **Job Overview** **Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating...


  • Desde casa, Colombia Intellias A tiempo completo

    Project Overview: Our client is an award-winning market leader in the smart home IoT category and is looking for a long-term strategic collaboration with the engineering team to help with the creation of innovative, smart home security solutions that deliver an exceptional user experience. - Senior Talent Delivery Specialist- Nadya...


  • Desde casa, Colombia 1840 & Company A tiempo completo

    Positi**on**: Senior Python Software Engineer Type: Freelance Full-Time Shift Schedule: 9 am - 5 pm UK time or 10 am - 6 pm UK Time **Ample opportunity to grow with the company as we scale.** Mandatory Pre-requisites - More than 2 years of relevant experience as a Senior Python Software Engineer - Need to install an RMM, MDM, and EDR on their laptops to...

  • IT Specialist

    hace 6 meses


    Desde casa, Colombia Roads Consulting A tiempo completo

    **Position Name**:IT Specialist We are a dynamic and rapidly growing company seeking an experienced Senior IT Specialist to join our talented team of consultants. We pride ourselves on delivering innovative solutions to our clients. We value collaboration, expertise, and a strong commitment to customer satisfaction. **Job purpose** As an IT Specialist,...


  • Desde casa, Colombia America At Work A tiempo completo

    The Manager - Information Security, Technology Risk Management resource will perform security assessments to ensure compliance with internal policies, controls, and standards, as well as client and regulatory security requirements. These assessments include evaluating technological, operational, and process controls to evaluate the design and implementation...


  • Desde casa, Colombia US-based Technical Concierge Company A tiempo completo

    **Technical Support Specialist - Colombia/Ecuador** **Compensation**: $6,000 - $7,200 yearly **Responsibilities**: - Identify, thoroughly research, and resolve intricate technical problems, documenting and monitoring their progress for timely resolution. - Ability to work in a fast-paced environment. - Diagnose, troubleshoot, and replicate customer...


  • Desde casa, Colombia IQVIA A tiempo completo

    Job Overview Perform tasks at a country level associated with Site Activation (SA) activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities. Essential Functions - Under general supervision, serve as...