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 regarding technical product information.

You will be constantly interfacing with the global and regional quality and regulatory organization to ensure that we are delivering precise quality and regulatory information attending the customers ́ expectations in what regards to timelines.

The scope of the job is regional, supporting regional and global customers across product lines.

  • Key Responsibilities:
  • Product knowledge to complete customer and internal technical information (documentation) requests for the Latam region and support to the global team;
  • Fulfill all documentation required by customers with a highlevel quality and regulatory information respecting the customers timeline;
  • Provide quality and regulatory support to customers in collaboration with other departments;
  • Review formulas for compliance in our systems against customers ́ requests and industry guidelines;
  • Able to provide regional support to the Global Key Accounts;
  • Deep understanding about the customers' requirements;
  • Primary contact to the customers;
  • Keep documentation updated according to the regulations and guidelines;
  • Support document automation by providing requirements and perform testing in the system;
  • Ability to spot potential issues about the customers documentation;
  • Provide support to our customers with expert advice and assistance in all documentation required;
  • Provide documentation support to sales, IC&D, for product safety and regulatory issues;
  • Understands the quality and regulatory framework to support customer's briefs;
  • Support business maintenance;
  • Contribute to the process improvement;
  • Feed database to measure KPIs.
  • Successfully manage the vast majority of all regulatory and quality needs (e.g. customer requests, regulatory changes and requirements etc.

Job Requirements:

Required Skills:


Bachelor's degree required in science or related fields, or similar level through experience plus 10 years in quality assurance and regulatory affairs experience or Masters degree plus 7 years experience.

Excellent oral and written communication skills.
Able to communicate effectively with our internal and external stakeholders.
Accountability and ownership about the process.
Problem solving and decision making skills.
Perform responsibilities with a positive attitude and an ability to work with a mínimal level of guidance and supervision.
Strategic Thinking, works independently and proactively - with timely and accurate results.
Hands-on mentality, service oriented, with good organizational skills, and high attention to detail.
Shows a proactive & self-driven approach to learning and execution.
Ability to draw information from various sources and work with cross functional teams.
Demonstrate ability in collaboration skills, working within a team, and work under pressure.
Functional Technical Skills in relevant discipline
Able to operate effectively within our regulatory systems and office systems.

Required Experience:

Mandatory:

  • Quality and/or Regulatory knowlodge across LATAM
  • Experience on delivering documentation to customers.
  • Spanish and English Fluent communication skills;
  • Full understanding of common office software (Excel, Word, Outlook, etc.)
  • Comfortable using IT platforms like CRM or SAP.
  • Ability to work with systems.

Job Relevant Competencies:

  • Ownership
  • Accountability
  • Be proactive
  • Organization
  • Commitment


 Communication
  • Good oral and written verbal fluency
  • Teamwork
  • Ability to discuss problems and potential decisions in the necessary time

Job Location:

  • Mexico

  • 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

    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 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 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 Specialist

    hace 4 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 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 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, 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,...

  • 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 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 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 7 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...

  • 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...

  • Regulatory Affairs Manager

    hace 4 semanas

    Buenos Aires, Argentina Bioceres Crop Solutions A tiempo completo

    We are looking for a Regulatory Affairs Manager to join our Bioceres Crop Solutions team! The 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...