Regulatory Affairs Manager

hace 7 meses


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 of Bioceres with global regulatory agencies, regulators and officials dealing with regulatory matters.

**Your main responsibilities will be**: Coordinate regulatory dossier preparation, international submissions, and process follow-up. Interact with cross-functional teams inside and outside the company. Maintain and strengthen networks with local authorities, trade associations and scientists. Keep close contact with various regulatory agencies and other related private, public and governmental entities. Participate on topic specific industry task forces, as well as other formal and informal groups. Drives the evaluation process for unplanned studies and activities. Prepare and monitor necessary budget. Coordinate the necessary studies for Submissions according Agencies requirements. Explore & Analyze Regulatory Policies. Have active role in stewardship initiatives.

Bioceres Crop Solutions es una empresa Argentina, nacida en la provincia de Buenos Aires, constituida en su totalidad por capitales argentinos y líder en el mercado de microbiología agrícola. Opera desde 1977 en la investigación, desarrollo, producción y comercialización de sus principales líneas de productos: Inoculantes, Terápicos para semillas, Biofertilizantes, Coadyuvantes, Micronutrientes, Pildorado de Semillas, Cebos para el control de plagas y Control de plagas en granos almacenados.
El futuro de la producción agropecuaria, la creciente demanda de alimentos, y el cuidado del medio ambiente son problemáticas que ocupan especial atención en el quehacer de la empresa. Llevar más vida al campo está en la esencia porque cada uno de los productos Bioceres Crop Solutions se orienta a cuidar y potenciar la vida de las semillas. Como consecuencia, la compañía posee certificación de normas ISO 9001, ISO 14001 y OSHAS 18001, obteniendo Certificación Trinorma de Calidad, Medio Ambiente, Seguridad y Salud.
Rizobacter Argentina está fuertemente posicionada en el mercado local y suma a esto una progresiva proyección con 8 subsidiarias en todo el mundo. A su vez, ya se encuentra comercializando sus productos en más de 40 países, consolidándose como empresa líder de productos microbiológicos en el mercado internacional.
Desde el 2019 Rizobacter forma parte del grupo accionario Bioceres Crop Solutions.

**Requisitos**:
Minimum of a BS degree is required, but no specific area.

Experience working with regulatory topics with Genetically Modified Plants.

Advanced English language.

**About your knowledge**:
l In-depth knowledge of regulations and requirements for submission of regulatory dossiers and paths for regulatory approval of biotech products in plants;
A good understanding of all regulatory relevant areas;
Knowledge in agrobusiness and competitive landscape of the industry.

Beneficios

Medical insurance for employee and family group.

Food reimbursement.

Training and development programs.

Discounts into the country with benefit platform.

Outdoors with the team members.

Annual bonus associated with performance.

Holiday business days.



  • 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

    hace 1 mes


    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 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, 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 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...


  • 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 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 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 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...


  • 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 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 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...


  • Capital Federal, Buenos Aires, Argentina The Coca-Cola Company 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 Bristol-Myers Squibb A tiempo completo

    **Working with Us** Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms...


  • Buenos Aires, Argentina Meta A tiempo completo

    **Public Policy Manager, Regulatory Responsibilities**: - Execute cross-functional regional/country-wide strategic initiatives, focused on legislative and product policy priorities - Monitor the political and regulatory environment in the region, and identify opportunities to advance policies and regulations that benefit the company and our local...


  • Buenos Aires, Argentina Philip Morris International A tiempo completo

    **Be a part of a revolutionary change** At PMI, we’ve chosen to do something incredible. We’re totally transforming our business - and building our future on one clear purpose - to deliver a smoke-free future. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter...


  • Buenos Aires, Argentina Parexel A tiempo completo

    A hard-working and driven professional, strongly focused in improving the quality of regulatory submission publishing activities and ensuring client’s expectations are delivered on time and with high quality. Monitors and shares industry changes by actively assisting and participating in Health Authorities webinars and workshops, sharing knowledge and...


  • 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...


  • Buenos Aires, Argentina Johnson & Johnson A tiempo completo

    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 salud de más de mil millones de pacientes y...


  • 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...