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 incorporates country-specific regulatory requirements, guidance, and other relevant regulatory intelligence into Regulatory submissions across the Area;
- Interacts with GRPTs and other key stakeholders across the enterprise to ensure regulatory milestones are properly communicated; provides timely updates on progress and/or issues that may impact the global program;
- Leads ARPTs to ensure that Regulatory programs can be effectively carried forward across all countries within the Area;
- Interacts with stakeholders across functions to ensure that Regulatory strategies are aligned with enterprise business objectives;
- Represents Area on process improvement initiatives of low
- to medium-complexity; is able to represents the needs of Area and Affiliates as appropriate;
- Leads team meetings effectively; appropriately escalates and drives issues to resolution; demonstrates good negotiation skills, effective group facilitation skills, and ability to drive consensus among team members;
- Develops effective working relationships with project team members; prepares and delivers clear, relevant, and influential deliverables for a variety of audiences;
- Incorporates diverse, cross-functional, and global perspectives into strategies & tactics that consistently enhance the ability to improve outcomes for the Regulatory Affairs organization.

**Qualifications** Required Education**:

- Bachelor’s degree in pharmacy, biology, chemistry, pharmacology etc.

**Preferred Education**:

- Advanced degree(s);
- English and Spanish are required. Portuguese fluency is preferred.

**Required Experience**:

- 5+ years’ related experience;
- Proven leadership skills and presence;
- Experience interfacing with government and health authorities;
- Experience working in a complex and matrix environment;
- Strong verbal and written communication skills;
- Ability to work with cross-functional teams;
- Ability to interact with different levels of stakeholders;
- Strong attention to detail and problem-solving skills;
- Effective use of negotiation skills to resolve issues in cross-functional teams to ensure completion of assigned tasks;
- Keen awareness to cultural nuances; proven ability to work in a global environment;
- Ability to successfully interact with multi-divisional and multi-functional teams from across the globe.

**Additional Information**

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:



  • 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 Vision Achievement A tiempo completo

    OverviewVision Achievement is a leading life sciences consulting firm dedicated to helping clients achieve excellence in regulatory affairs and quality assurance.


  • Buenos Aires, Buenos Aires C.F., Argentina Vision Achievement A tiempo completo

    Company OverviewVision Achievement is a top-rated life sciences consulting firm that delivers high-quality services to clients in the industry.Salary: $120,000 - $180,000 per yearJob Description:We are seeking an experienced Senior Regulatory Affairs Specialist to join our team. As a key member of our consulting team, you will be responsible for planning and...


  • Buenos Aires, Argentina AbbVie A tiempo completo

    **Company Description** The mission of the Botox & AA Regulatory Affairs Coordinator is to be responsible for the regulatory activities related to Botox and aesthetic products in Argentina and Chile, aligned to business needs, to assure compliance with local regulations and with AbbVie policies. - Regulatory Affairs activities - Devise regulatory...

  • Regulatory Affairs

    hace 6 meses


    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...


  • 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...


  • 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 3 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...


  • 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...


  • 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...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds - through a unique combination of deep human understanding...


  • 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, 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...


  • Buenos Aires, Argentina Haleon A tiempo completo

    Hello. We’re Haleon. A new world-leading consumer health company. Shaped by all who join us. Together, we’re improving everyday health for billions of people. By growing and innovating our global portfolio of category-leading brands - including Sensodyne, Corega, Centrum, Alikal, Uvasal, Hinds - through a unique combination of deep human understanding...


  • Buenos Aires, Buenos Aires C.F., Argentina Vision Achievement A tiempo completo

    Job DescriptionWe are seeking an experienced Life Sciences Regulatory Affairs Consultant to join our team at Vision Achievement.About the Role:This exciting opportunity is for independent contractors with significant experience in RA/QA aspects of life sciences industry sub-sectors such as medical devices, in vitro diagnostics, lab developed tests,...


  • Buenos Aires, Buenos Aires C.F., Argentina Vision Achievement A tiempo completo

    About the RoleWe are seeking a highly experienced and skilled Senior Life Sciences Regulatory Affairs Professional to join our team at Vision Achievement. This exciting opportunity is for an independent contractor with significant experience in RA/QA aspects of life sciences industry sub-sectors such as medical devices, in vitro diagnostics, lab developed...


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

    About the CompanyOur client, a pioneer in high-tech medical and aesthetic devices, is renowned for its cutting-edge technology and commitment to innovation. With a global presence spanning multiple continents, this international organization is at the forefront of regulatory compliance and product safety.Job OverviewIn this pivotal role as a Regulatory...


  • Buenos Aires, Argentina Coca-Cola A tiempo completo

    Are you an expert in scientific and regulatory affairs with a strong advocacy mindset and robust experience within the food industry? We're looking for a proactive professional who is not only abreast of the constantly evolving regulatory landscape but is also adept at identifying potential risks and opportunities. If this sounds like you, this role could...


  • 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...


  • 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...