Regulatory Affairs Specialist, Latam

hace 1 semana

Buenos Aires, Argentina Novasyte 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.

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world. Learn more at

  • Regulatory Affairs Specialist

    hace 3 días

    Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives **In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Buenos Aires, Argentina Medtronic A tiempo completo

    **Careers that Change Lives**In this exciting role as a Regulatory Affairs Specialist, you will lead and prepare Regulatory Affairs (RA) meetings (regulatory status) involving cross-functional business partners under your responsibility. To provide status on time about projects and all applicable regulatory activities assigned per Senior Supervisor or RA...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Capital Federal, Buenos Aires, Argentina Abbott Laboratories A tiempo completo

    **Regulatory Affairs Specialist** **About Abbott** Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology. **The Opportunity** This position is sited in **Retiro **(Edificio Laminar) in our **Diagnostics Division**:...

  • Regulatory Affairs Specialist

    hace 2 semanas

    Buenos Aires, Argentina 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...

  • Regulatory Affairs

    hace 1 semana

    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...

  • Regulatory Affairs

    hace 2 semanas

    Buenos Aires, Argentina International Flavors & Fragrances A tiempo completo

    This position is key and strategic to the Global Regulatory Affairs organization to meet the strategy to be a premier partner to our customers. Customers need detailed information about our products, quality systems, 3rd party certifications, regulatory compliance and others. In this role you will be responsible to deliver documentation; answering inquiries...

  • Regulatory Affairs Specialist

    hace 3 semanas

    Buenos Aires, Argentina ABBVIE A tiempo completo

    PURPOSE STATEMENT The mission of the Regulatory Affairs Analyst is to cooperate with the Regulatory team in several activities related to the area. The primary goals are in providing support in registration of products for Oncology and new Specialty portfolio, labeling for Region South and the activities required to release product to the Argentinean...

  • Regulatory Affairs Associate

    hace 2 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...

  • Regulatory Affairs Associate

    hace 3 semanas

    Buenos Aires, Argentina IQVIA A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...

  • Regulatory Affairs Associate

    hace 3 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. Work with the Manager of Regulatory Affairs to provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and...

  • Manager, Regulatory Affairs, International

    hace 3 semanas

    Buenos Aires, Argentina Novasyte A tiempo completo

    Introduction/Purpose The Manager, Regulatory Affairs International supports ambitious geographical expansion plans. The position will support registration of existing portfolio products into new territories and to register several of development projects into the international region. This role is key to driving both the Regulatory strategy and...

  • Regulatory Affairs Coordinator

    hace 2 semanas

    Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    Regulatory Affairs Coordinator - Argentina: Work mode: Hybrid Onsite Location(s): Buenos Aires, ArgentinaAdditional Locations: N/ADiversity - Innovation - Caring - Global Collaboration - Winning Spirit - High PerformanceAt Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing...

  • Regulatory Affairs Coordinator

    hace 6 días

    Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **Regulatory Affairs Coordinator - Argentina**: - Work mode: Hybrid- Onsite Location(s): Buenos Aires, Argentina**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...

  • Regulatory Affairs Manager

    hace 2 semanas

    Buenos Aires, Argentina Bioceres Crop Solutions A tiempo completo

    We are looking for a Regulatory Affairs Manager to join our Bioceres Crop Solutions teamThe mission of the position is to give support and execute Bioceres regulatory strategy for biotechnological traits and products on target crops, in order to obtain and maintain regulatory approvals in all relevant locations at a timely manner.Be the primary interface of...

  • Sr. Associate Regulatory Affairs

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Career Category Regulatory **Job Description**: Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase...

  • Regulatory Affairs Senior Analyst

    hace 2 semanas

    Buenos Aires, Argentina Kenvue A tiempo completo

    Regulatory Affairs Senior Analyst WDescription En Johnson & Johnson, la compañía de cuidado de la salud más grande del mundo, nos unimos con un propósito: transformar la historia de la salud en la humanidad._ La diversidad y la inclusión son esenciales para continuar construyendo nuestra historia de pioneros e innovación, que ha estado impactando la...

  • Regulatory Affairs Project Leader

    hace 1 semana

    Capital Federal, Buenos Aires, Argentina Raffo A tiempo completo

    Capital Federal, Capital Federal, Argentina Salud, Medicina y Farmacia/Farmacéutica Full-time Presencial Descripción del puesto Nos encontramos en la búsqueda de un Regulatory Affairs Project Leader para Nuevas Licencias para el área de Asuntos Regulatorios (prod. de licencias) Los principales desafíos serán - Sólida experiência realizada...

  • Sr. Associate Regulatory Affairs

    hace 3 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Sr. Associate Regulatory Affairs Ensure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a...

  • Regulatory Affairs Coordinator

    hace 2 semanas

    Buenos Aires, Argentina UPL ltd A tiempo completo

    Regulatory Affairs Coordinator:Job Id: 4555- City: Buenos Aires, Buenos Aires, Argentina- Department: REGISTRATIONS- Function: Regulatory, Research and Development- Employee Type: Permanent Full Time- Seniority Level: Not Applicable- Description:Somos UPL, somos OpenAg y nos comprometemos a seguir construyendo una red agrícola que alimente el crecimiento...

  • Sr. Associate Regulatory Affairs

    hace 2 semanas

    Buenos Aires, Argentina Amgen A tiempo completo

    Sr. Associate Regulatory AffairsEnsure life-cycle management for local products and production facilities as local regulatory lead for selected products (biologics and synthetic). Support RA senior staff, interface with the product teams, international regulatory, local QA/QC and supply chain. Interphase when specific strategies or activities that impact a...