Regulatory Specialist Ii

hace 1 semana


Buenos Aires, Argentina IQVIA A tiempo completo

Job Overview

Essential Functions
- Acts as a Regulatory Team Leader on more complex projects, which may include technical writing;
- Prepares and/or reviews regulatory documentation in area of expertise, as appropriate;
- Establishes relationships with many customers; may meet face to face without rest of the team to discuss regulatory issues, present lessons learned and discuss customer comments;
- Acts as an SME/ expert in Regulatory knowledge in Chemistry, Manufacturing and Controls/ Lifecycle Maintenance/ Marketing Authorization Transfers/ Labeling/ Publishing as applicable;
- Understands the Scope of Work, deliverables and management of budget for any given project and manages workload as appropriate;
- May give guidance to junior colleagues, including feedback on the quality of technical documents, and may assist in their training and development;
- May present to clients on complex regulatory processes at large full service bid defense meetings by phone or in person;
- May act as reviewer for regulatory standard operating procedures, as assigned and appropriate;
- May prepare and deliver regulatory training to IQVIA small groups or individuals;
- Performs other tasks or assignments, as delegated by Regulatory management;

Qualifications
- Bachelor's Degree Degree in Lifescience or related discipline Req Or
- Master's Degree Degree in Lifescience or related discipline Req
- At least 3-4 years relevant experience
- Good understanding of the Research and Development process (Chemistry, Manufacturing & Controls, Preclinical and Clinical), laws and related guidelines, as appropriate;
- Possesses a specific regulatory or technical expertise;
- Good, solid interpersonal communication (oral and written) and organisation skills;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Demonstrates self-motivation and enthusiasm;
- Ability to work on several projects, with direction from senior staff as appropriate;
- Ability to follow standard operating porcedures consistently; provides independent thought to assist in process improvements;
- Ability to make decisions on discrete tasks under senior supervision;
- Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education;
- Makes adjustments or recommended enhancements in systems and processes to solve problems or improve effectiveness of job area;
- Problems faced are general and may require understanding of broader set of issues, but typically are not complex;
- Ability to adapt quickly to a rapidly changing environment;
- Applicable certifications and licenses as required by country, state, and/or other regulatory bodies



  • Buenos Aires, Argentina FullStack Labs A tiempo completo

    Regulatory & Start Up Specialist We are looking for a Regulatory & Start Up Specialist to join our FSP team in a Home Based role! What You'll Do 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...


  • Buenos Aires, Argentina Prometeo Talent A tiempo completo

    Regulatory Affairs Specialist – Regulatory Affairs / Southern Cone 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...


  • Buenos Aires, Argentina Syneos Health, Inc. A tiempo completo

    A biopharmaceutical solutions organization is seeking a Medical Editor II to ensure quality formatting of clinical and regulatory documents according to established guidelines. This role involves defining document scope with authors, maintaining standards in compliance with regulatory information, and communicating effectively with stakeholders to manage...


  • Buenos Aires, Argentina Citi A tiempo completo

    The Regulatory Risk Analyst II is a developing professional role. Applies specialty area knowledge in monitoring, assessing, analyzing and/or evaluating processes and data. Identifies policy gaps and formulates policies. Interprets data and makes recommendations. Researches and interprets factual information. Identifies inconsistencies in data or results,...


  • Capital Federal, Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

    **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 and high-performing employees, tackling some of the most important health industry challenges. With access to...


  • Buenos Aires, Argentina Syneos Health group A tiempo completo

    A leading biopharmaceutical solutions organization is seeking a Medical Editor II to ensure the quality of clinical and regulatory documents are formatted to specific requirements. This entry-level role involves managing document formatting with authors, performing quality reviews, and ensuring consistency with templates. Ideal candidates will have strong...


  • Buenos Aires, Argentina Avra Talent A tiempo completo

    Regulatory Affairs Specialist Organon is a Women’s Health Company that believes in a better and healthier every day for every woman! We are a passionate, global community of thousands dedicated to redefining the future of women’s health. Our mission is to deliver impactful medicines and solutions for a healthier everyday. But what really makes it work at...

  • She Specialist Ii

    hace 2 semanas


    Buenos Aires, Argentina Garaje de ideas A tiempo completo

    As a Safety, Health & Environment (SH&E) Specialist the mission of your role is to drive, coordinate and prioritize site SH&E process and projects, to guide and advise the internal stakeholders in the delivery of all Safety, Occupational Health, and Environment results. To ensure the site is always in compliance with applicable legal and regulatory...


  • Buenos Aires, Argentina Schlumberger A tiempo completo

    **Regulatory Compliance Specialist**: Buenos Aires - Argentina El/La Regulatory Compliance Specialist es responsable de ejecutar el programa de Cumplimiento Normativo de Schlumberger y sus componentes, y de proporcionar apoyo general en cuestiones de cumplimiento a los clientes internos y a las partes interesadas dentro del territorio...


  • Buenos Aires, Argentina BEON Tech Studio A tiempo completo

    Regulatory Submissions Specialist (with Portuguese) IQVIA This role will require special working days as National Holidays and weekends. Job Overview As a Regulatory Reporting Specialist, you will be involved in submitting safety reports to regulatory authorities. Review, assess, and process safety data and information received from various sources....