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Regulatory Affairs Specialist Chile
hace 2 meses
Guerbet is a global leader in medical imaging, offering a comprehensive portfolio of pharmaceuticals, medical devices, digital, and AI solutions for diagnostic and interventional imaging. Our purpose is to enable people to live better by building lasting relationships and innovating continuously.
Job SummaryWe are seeking a highly skilled Regulatory Affairs Coordinator to join our team in Chile. As a key member of our regulatory team, you will be responsible for coordinating the preparation and assembly of regulatory submissions for medical devices and pharmaceutical products, ensuring timely completion and filing as required in Chile.
Key Responsibilities- Coordinate regulatory submissions tracking process in Chile, establishing timelines for product maintenance submissions.
- Support in-country regulatory consultants and/or local distributors through Latin America to ensure filling of regulatory submissions to the respective regulatory bodies.
- Be aware of the regulatory strategy of the company.
- Manage regulatory submissions tracking process in Chile, establishing timelines for product maintenance submissions.
- Closely supervise regulatory consultants and/or local distributors in Latin America, mainly for SOLA (South Latin America) regarding the regulatory activities relating to Guerbet products.
- Coordinate with the local regulatory team the proper submission documents needed during the life cycle of the products in Chile.
- Interact with local regulatory bodies where needed or through local in-country consultants to discuss project feasibility, strategies to achieve fast-track approvals, and assess the impact of change control for the regional marketing authorizations.
- Ensure that all product lifecycle information (approvals, notices, rejections, or any other information with regulatory impact) are provided to Headquarters in a timely manner.
- Represent the Manager/Director in meetings of class entities and/or in meetings with regulatory bodies, as delegated.
- Maintain internal processes in accordance with local and regional legislations, and global procedures.
- Assist the LATAM Regulatory Affairs Manager on regulatory projects for Chile and for distributors in SOLA.
- Provide regulatory support for other corporate areas.
- Analyze, translate, prepare, or adapt the technical documentation in accordance with the legislation in force for the registration, variations, processes, and certifications of good manufacturing practices, according to the reference documents, meeting the established deadlines.
- Monitor and perform review, update, and maintenance of packaging and labeling artworks workflow for Chile and distributors, when applicable, to follow regulatory authorities and headquarter datasheet.
- Perform and supervise the procedures to include the products in the public health system, when feasible.
- Create, modify, put in force, or withdraw SOPs on regulatory affairs matters.
- Develop and conduct training programs regarding regulatory affairs.
- Assume the position of Technical Director (pharmacist in charge) of the Chilean affiliate before the competent local health authorities, performing all required roles.
- Academic background: bachelor's degree or equivalent in health sciences, chemical pharmaceutical discipline, or related (Essential) with an active registration in the respective Regional Council.
- Previous experience as Technical Director in a pharmaceutical company is desirable.
- Solid knowledge of the legislation for medicines and medical devices in the applicable countries.
- Fluency in English.
- At least 5 years of previous Regulatory experience.
- Experience working with external consultants.
- Adapted to work in matrix reporting environment.
- Self-motivated to work in a multicultural environment.
- Knowledge of standard Office software packages (e.g., Word, Excel).
- Availability to travel when needed.
At Guerbet, we value diversity of talents coming from various horizons. We believe that no individual should be discriminated against because of their differences. We are an Equal Opportunity Employer and are committed to creating an inclusive environment for all employees.
We offer continued personal development and a unique role in the future of medical imaging. Join our team and be part of a multicultural team of 2,600 people across more than 20 countries.
