Senior Specialist, Regulatory

hace 3 días


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 **.



  • Buenos Aires, Buenos Aires C.F., Argentina Takeda A tiempo completo

    Takeda is seeking a Senior Regulatory Specialist to join our team. In this role, you will be responsible for providing regulatory expertise on drug development, registration, and life-cycle management.Key Responsibilities:Provide regulatory expertise on drug development, registration, and life-cycle management.Communicate effectively with stakeholders,...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Senior Regulatory SpecialistRemote OpportunityLifelancer is seeking an experienced Senior Regulatory Specialist to join our team. As a key member of our regulatory department, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the life sciences industry.Key Objectives:Develop and maintain expertise in regulatory...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Job Title: Senior Regulatory SpecialistNew England Area or Remote OpportunityWe are seeking a highly skilled and experienced professional to join our regulatory department as a Senior Regulatory Specialist. This key role involves ensuring compliance with regulatory requirements and guidelines in the life sciences industry.Key Responsibilities:Develop...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Senior Regulatory Affairs SpecialistNew England Area OpportunityLifelancer is seeking a highly experienced Senior Regulatory Affairs Specialist to join our team. In this key role, you will be responsible for ensuring compliance with regulatory requirements and guidelines in the life sciences industry.Key Responsibilities:Develop and maintain comprehensive...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    About the Role:We are seeking a highly skilled Senior Regional Regulatory Affairs Specialist to join our team in the Asia Pacific region. The successful candidate will be responsible for ensuring compliance with regulatory requirements across multiple countries.Key Accountabilities:Develop and implement regional regulatory strategies ensuring compliance with...


  • 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...


  • Buenos Aires, Buenos Aires C.F., Argentina Mondelēz International A tiempo completo

    **About the Role**This is a unique opportunity to join our team as a Regulatory Compliance Specialist. As a key member of our organization, you will play a crucial role in ensuring that our business operations are compliant with relevant laws and regulations.In this position, you will be responsible for organizing and structuring meetings, resources,...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Company ProfileLifelancer is a leading talent-hiring platform specializing in Life Sciences, Pharma, and IT. Our mission is to connect professionals with opportunities that drive innovation and growth.Job DescriptionWe are seeking a skilled Senior Regulatory Manager to join our team. The successful candidate will be responsible for developing and...


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

    Bitfinex, a digital asset trading platform, is on a mission to create the most innovative cryptocurrencies exchange. As a leading player in the industry, we require an experienced Financial Regulatory Specialist or Crypto-Asset Licensing Expert to join our Regulatory and Licensing team.Company OverviewFounded in 2012, Bitfinex offers state-of-the-art...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Job OverviewLifelancer is a talent-hiring platform connecting professionals with opportunities in pharma, biotech, health sciences, healthtech and IT domains.About the RoleWe are seeking a Senior Regulatory Manager to join our team. As a key member of our organization, you will be responsible for ensuring compliance with regulatory requirements across...


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

    Job RequirementsWe are seeking a seasoned Senior Regulatory Advisor to provide expert guidance on regulatory matters for our Tether Evo business vertical.As a key member of our team, you will be responsible for ensuring compliance with national and international regulations and shaping the regulatory landscape for biotech.Key Responsibilities:Developing and...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Job OverviewLifelancer is seeking an experienced Senior Regulatory Affairs Specialist to support the development and submission of regulatory documents for pharmaceutical and biotechnology products in the US market.This role requires excellent knowledge of FDA regulations, strong analytical skills, and the ability to work effectively in a remote environment....


  • Buenos Aires, Argentina Seqirus A tiempo completo

    Please present resumes in English **The Opportunity** You will be a technical specialist within LATAM Region and will have the opportunity to shae the vision and goals for Global Regulatory Affairs and Seqirus, by providing specialist, regional advice and support. You will partner with other functions in Regulatory Affairs (e.g. Global Regulatory Leads,...


  • Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific Gruppe A tiempo completo

    Job DescriptionThe Regulatory Affairs Specialist II will be responsible for the development and implementation of regulatory strategies to support the commercialization of medical devices. Key responsibilities include coordinating regulatory submissions, assessing product changes for regulatory compliance, and representing Regulatory Affairs in...


  • Buenos Aires, Buenos Aires C.F., Argentina Boston Scientific Corporation A tiempo completo

    OverviewBoston Scientific Corporation is a leader in medical science with over 40 years of experience. Our mission is to advance science for life by transforming lives through innovative medical solutions.Job DescriptionWe are seeking a skilled Regulatory Affairs Specialist II to join our team. The successful candidate will develop local strategies for...


  • Buenos Aires, Buenos Aires C.F., Argentina Amway Inc. A tiempo completo

    At Amway Inc., we're seeking a highly skilled Regulatory Compliance Specialist to join our team.Job DescriptionAs a key member of our product safety and regulatory compliance team, you will be responsible for ensuring the compliance of assigned product lines and markets with relevant regulations.Main Responsibilities:Conduct concept/category reviews, label...


  • 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...


  • Buenos Aires, Buenos Aires C.F., Argentina Lifelancer A tiempo completo

    Job Overview:Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma and IT. Our client seeks a Senior Regional Regulatory Affairs Specialist to join their team in the Asia Pacific region.Key Responsibilities:Develop and implement regional regulatory strategies ensuring compliance with relevant regulations...


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

    We are searching for a Crypto Regulation Specialist to join our Regulatory and Licensing team. As a specialist, you will contribute to the process of obtaining necessary license approvals in identified markets. You will have a focus on translating regulatory requirements into clear and actionable strategic recommendations, managing relationships and...