Regulatory Affairs Specialist, Latam

hace 3 meses

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 information, guidance, training, support and strategic planning based on applicable regulations and guidances issued by the applicable regulatory agency(ies) to the project team.
- Identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
- Leads the preparation, submission and maintenance of regulatory filings with relevant health authorities
- Ensure the compilation and maintenance of pertinent documentation (e.g., files) required for regulatory compliance for assigned clinical research projects.
- Serve as a member of groups, teams, or committees related to regulatory affairs, and quality assurance or other designated IQVIA Biotech activities, as appropriate.
- Serve as IQVIA Biotech liaison with central IRBs.
- Perform other related duties as assigned.

**KNOWLEDGE, SKILLS AND ABILITIES**:

- Working knowledge of and aptitude for activities related to regulatory affairs and quality assurance, both domestic and international.
- Familiarity with or ability to become familiar with regulatory documents, general contents, organization and the methods of filing and tracking.
- Familiarity with or ability to become familiar with principles of Good Clinical Practice, Good Laboratory Practice and Good Manufacturing Practice., ISO standards.
- Extensive knowledge of clinical research; knowledge and familiarity with 21CFR11 and EDC systems.
- Experience in preparation of audit plans and checklists against applicable standards, execution of audits, and preparation of comprehensive written audit reports.
- Good interpersonal skills with the ability to communicate effectively, both orally and in writing, with all levels of staff, and with the public.
- Ability to be detail oriented with background adequate to deal with scientific issues related to technical regulations and SOPs.
- Ability to read and synthesize technical material and to prepare clear and concise written documents.
- Computer literate at a level allowing utilization of event tracking programs, data loading and information processing related to regulatory affairs and quality assurance.

**CRITICAL JOB FUNCTIONS IN ACCORDANCE WITH ADA CRITERIA**:

- Ability to travel domestically and internationally 20%
- Very limited physical effort required to perform normal job duties

**MINIMUM RECRUITMENT STANDARDS**:

- Requires Bachelor's degree with at least 3 years of related work experience, with 2 or more years in regulatory affairs, quality assurance and/or clinical research, or equivalent level of education, training and experience.
- Science degree preferred.
- Excellent analytical and communication skills, particularly writing skills, are essential.
- Must be familiar with and able to identify and interpret regulations, guidelines, and other pertinent information issued by applicable regulatory bodies.
- Must be able to independently coordinate with interdisciplinary team members, manage timelines for and compile documents for pre-IND and IND submissions, with oversight from Regulatory Management.
- Demonstrated Clinical, Pre-clinical and or CMC knowledge for chemical or biologic products preferred.
- Demonstrated computer literacy is required.

  • Senior Regulatory Affairs Specialist

    hace 4 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...

  • Principal Regulatory Affairs Specialist

    hace 3 meses

    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...

  • Senior Reg Affairs Specialist

    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...

  • Regulatory Affairs Consultant

    hace 4 meses

    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 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...

  • 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...

  • Regulatory & Start Up Specialist 1

    hace 4 meses

    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...

  • Regulatory & Start Up Specialist 1

    hace 4 meses

    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...

  • Communication Specialist

    hace 4 meses

    Desde casa, Colombia STEFANINI LATAM A tiempo completo

    **¡Sé parte de Stefanini!** En Stefanini somos más de 30.000 genios, conectados desde 40 países, haciendo lo que les apasiona y co-creando un futuro mejor.? **Responsabilidades y atribuciones** - Ingles B2 - Buscamos a una persona con formación académica de Comunicador - al menos 3 años de experiência en la gestión de estrategias de comunicación,...

  • Intake Specialist

    hace 3 meses

    Desde casa, Colombia GCR Latam A tiempo completo

    This is a full-time remote role for an Intake Specialist for a Personal Injury Law Firm. The Intake Specialist will be responsible for communicating with clients, conducting client intake interviews, utilizing interpersonal skills to connect with potential clients, and providing excellent customer service to clients. **Qualifications**: - Excellent...

  • Outbound Specialist

    hace 5 meses

    Desde casa, Colombia Tripaneer A tiempo completo

    **Tripaneer is looking for a full-time home-based independent contractor who is based in LATAM and who can provide Outbound services, with cold calling and partnership management experience.** As Tripaneer continues to expand our business globally, we are always looking for the best and brightest who share our passion for enriching lives through...

  • Legal and Regulatory Risk Specialist

    hace 4 meses

    Desde casa, Colombia Bold A tiempo completo

    **Bold** Nuestra compañía fue fundada en mayo de 2019 por un equipo de personas increíbles y con una experiência única, el grupo de fundadores está conformado por los creadores de PayU Latam y otras empresas expertas en tecnología financiera. Estamos creando soluciones de pago y de banca para MiPymes, independientes y emprendedores en Colombia....

  • Local Safety Officer

    hace 4 meses

    Desde casa, Colombia ProductLife Group A tiempo completo

    PLG is currently seeking a highly motivated individual for the position of Local Safety Officer in Colombia or Mexico. As a vital member of our team, you will be responsible for ensuring compliance with local and international safety regulations in the pharmaceutical industry. Join us in our mission to uphold the highest standards of safety and quality in...

  • IT Talent Acquisition Specialist

    hace 3 meses

    Desde casa, Colombia Bold A tiempo completo

    **Bold** Nuestra compañía fue fundada en Mayo de 2019 por un equipo de personas increíbles y con una experiência única, el grupo de fundadores está conformado por los creadores de PayU Latam y otras empresas expertas en tecnología financiera. Estamos creando soluciones de pago y de banca para MiPymes, independientes y emprendedores en Colombia....

  • Customer Support Specialist

    hace 4 meses

    Desde casa, Colombia Heinsohn Business Technology A tiempo completo

    Heinsohn Business Technology is a Colombian software company with a wide range of clients across the Americas is looking for top-notch professionals to be part of our international team as Application support specialist to rock it! Let's grow together in a multicultural team! Tasks You'll be part of an international teamwork where you'll have different...

  • Regulatory Reporting Project Manager

    hace 3 meses

    Desde casa, Colombia Bold A tiempo completo

    **Bold** Nuestra compañía fue fundada en Mayo de 2019 por un equipo de personas increíbles y con una experiência única, el grupo de fundadores está conformado por los creadores de PayU Latam y otras empresas expertas en tecnología financiera. Estamos creando soluciones de pago y de banca para MiPymes, independientes y emprendedores en Colombia....

  • Study Start-up Specialist I/ii, Bogota, Colombia

    hace 4 meses

    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...

  • Content & Copy Specialist

    hace 4 meses

    Desde casa, Colombia Bold A tiempo completo

    **Bold** Nuestra compañía fue fundada en Mayo de 2019 por un equipo de personas increíbles y con una experiência única, el grupo de fundadores está conformado por los creadores de PayU Latam y otras empresas expertas en tecnología financiera. Estamos creando soluciones de pago y de banca para MiPymes, independientes y emprendedores en Colombia....

  • Sales Talent Acquisition Specialist

    hace 3 meses

    Desde casa, Colombia Bold A tiempo completo

    **Bold** Nuestra compañía fue fundada en Mayo de 2019 por un equipo de personas increíbles y con una experiência única, el grupo de fundadores está conformado por los creadores de PayU Latam y otras empresas expertas en tecnología financiera. Estamos creando soluciones de pago y de banca para MiPymes, independientes y emprendedores en Colombia....