Senior Specialist, Regulatory

hace 1 mes

Buenos Aires, Argentina Worldwide Clinical Trials A tiempo completo

**Who we are**

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

**Why Worldwide**

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us

**What you will do
- Responsible for supporting end-to-end site start-up from site identification to site activation and maintenance serving as the primary point of contact for the site
- Act as internal primary point of contact at country level for regulatory and site activation activities in the assigned studies
- Responsible for customization of country specific patient information sheet, informed consent form, labels and local regulatory documents to comply with ICH GCP & country specific requirementsReview and provide advice on country timelines for the assigned studies

**What you will bring to the role
- Strong organizational and management skills
- Self-motivated learning about current regulatory processes and intelligence
- Excellent written and verbal communication skills to clearly and concisely present information
- Team-oriented work style; seeks and gives guidance to others
- Strong interpersonal skills in a fast-paced, deadline oriented, and changing environment
- Excellent ability to handle multiple tasks in a fast-paced and changing environment

**Your background
- A minimum four-year college curriculum with a major concentration in medical, biological, physical, health, pharmacy or other related science
- Minimum one year of experience in clinical research, in regulatory-related function
- Good knowledge of ICH GCP, EU Clinical Trials Directive and other relevant clinical research conduct guidanceMultilingualism preferred; fluent in local language; working knowledge of English

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We’re on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law **.

  • Regulatory Affairs Specialist

    hace 6 meses

    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 Specialist for LATAM Region

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Tether Operations Limited A tiempo completo

    Tether Operations Limited, a pioneering company in the cryptocurrency industry, is seeking an experienced Regulatory Specialist to join its team.Job OverviewWe are looking for a highly skilled and motivated individual with expertise in regulatory affairs within the financial services and crypto-asset industries. The successful candidate will be responsible...

  • Regulatory Affair Specialist

    hace 2 meses

    Buenos Aires, Argentina ITEX A tiempo completo

    About the Company: Our client is a global leader in producing high-tech medical and aesthetic devices, known for their use of valuable materials and sophisticated design. With offices and manufacturing facilities in the USA, UK, Bratislava, India, and other countries, this international company is at the forefront of innovation in its field.Job Overview:As a...

  • Crypto Regulatory Specialist for LATAM Markets

    hace 1 mes

    Buenos Aires, Buenos Aires C.F., Argentina Bitfinex A tiempo completo

    Job OverviewBitfinex, a leading digital asset trading platform, is seeking an experienced Crypto Regulatory Specialist to join our Regulatory and Licensing team in LATAM markets.We're on the lookout for a highly skilled professional with a deep understanding of legal and regulatory requirements in the crypto-asset industry. If you have expertise in...

  • Regulatory Compliance Specialist for Clinical Trials

    hace 1 mes

    Buenos Aires, Buenos Aires C.F., Argentina IQVIA A tiempo completo

    We are seeking an experienced Regulatory Compliance Specialist to join our team in Argentina & Mexico. This is a home-based role, allowing you to work remotely and enjoy the benefits of a dynamic environment.About the Role:As a Regulatory Compliance Specialist, you will be responsible for performing tasks at a country level associated with Site Activation...

  • Regulatory Affairs Specialist

    hace 2 meses

    Buenos Aires, Argentina AbbVie A tiempo completo

    **Company Description** **Major Responsibilities**: - Provides strategic direction to support the development of compliant and competitive Regulatory programs; - Manages the preparation and review of regulatory submissions consistent within Regulatory requirements and guidelines to drive complete and timely information to Health Authorities; - Effectively...

  • Regulatory & Start Up Specialist, cFSP

    hace 6 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    We are looking for a Regulatory & Start Up Specialist to join our cFSP team in a Home Based role! Location : Argentina & México 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...

  • Fsp - Sr. Regulatory & Start Up Specialist

    hace 2 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** The **Regulatory & Start Up Specialist** will 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, Fsp

    hace 6 meses

    Buenos Aires, Argentina Novasyte A tiempo completo

    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 contractual/budgetary...

  • Regulatory Intelligence Specialist

    hace 3 semanas

    Buenos Aires, Buenos Aires C.F., Argentina CUBE A tiempo completo

    About CUBEWe are a global RegTech business defining and implementing the gold standard of regulatory intelligence and change for the financial services industry.

  • Fsp - Regulatory and Start Up Specialist 2 - Arg

    hace 7 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    **Job Overview** The **Regulatory & Start Up Specialist 2** will 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...

  • Senior Operations Specialist

    hace 1 mes

    Buenos Aires, Argentina IBC Ventures LTD A tiempo completo

    IBC Group is a leading advisory firm, committed to providing innovative solutions and insights in various industries. We are seeking a highly skilled Senior Operations Specialist to join our dynamic team. Preferably, the candidate will have a background in cryptocurrency to further enhance our operations in this rapidly evolving sector. Key...

  • FSP - Regulatory and Start Up Specialist 2 - ARG

    hace 7 meses

    Buenos Aires, Argentina IQVIA A tiempo completo

    Job Overview The Regulatory & Start Up Specialist 2 will 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. ...

  • Senior Specialist, Quality Assurance Auditor

    hace 6 meses

    Buenos Aires, Argentina Organon A tiempo completo

    **Description of The Position** The Senior Specialist, Quality Assurance Auditor, ensures quality and compliance with local and international regulatory requirements by conducting internal and external audits. This role provides guidance to internal stakeholders, assisting in the establishment of the company's compliance strategy and the resolution and...

  • Digital Sales Development Senior Specialist

    hace 4 meses

    Buenos Aires, Argentina SAP A tiempo completo

    **What we offer** **Sales Development** Responsible for building and nurturing pipeline of sales opportunities and incremental revenue aligned with the Sales and Marketing teams, focusing on leads within their assigned space. Nurture and develop the opportunities through the digital tools available once they have moved into the sales cycle, transition them...

  • Senior Associate Regulatory Affairs

    hace 7 meses

    Buenos Aires, Argentina Amgen A tiempo completo

    **HOW MIGHT YOU DEFY IMAGINATION?** If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering...

  • Regulatory Affairs

    hace 4 semanas

    Buenos Aires, Argentina Parexel A tiempo completo

    A Regulatory Affairs 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. A Project Leader must be technically competent and continually developing the skills as defined in the department, under general direction of his/her Line Manager and...

  • Regulatory Affairs, Study Start Up Specialist

    hace 7 meses

    Buenos Aires, Argentina Mexico A tiempo completo

    **ALL CV´s MUST BE SUBMITTED IN ENGLISH IN ORDER TO BE CONSIDERED!** **Essential Functions**: - Assist/Advise project teams on all regulatory requirements for clinical studies - Perform compliance assessments according to country requirements and document any activity discovered; notify Project Managers of any findings - Review and adapt study specific...

  • Senior SAP HCM PY Specialist

    hace 1 mes

    Buenos Aires, Buenos Aires C.F., Argentina Alight A tiempo completo

    Alight Inc, a global leader in HR and workforce solutions, is seeking an experienced SAP HCM PY Specialist to join our team.About the RoleWe are looking for a highly skilled professional to provide expert-level support for our payroll operations. As a Senior SAP HCM PY Specialist, you will be responsible for delivering high-quality consulting services,...

  • Senior Software Lifecycle Specialist

    hace 4 semanas

    Buenos Aires, Buenos Aires C.F., Argentina Chevron A tiempo completo

    Job OverviewChevron, a leading multinational energy corporation, seeks a highly skilled Senior Software Lifecycle Specialist to join its IT Organization. This position plays a pivotal role in the software development lifecycle with a primary focus on maintaining vendor software, optimizing evergreen support, and supporting in-house developed applications.