09 oct
Guerbet
Santiago
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years, we continuously innovate. We dedicate 10% of our revenue to Research & Development to improve the diagnosis, prognosis, and quality of life of patients.
Achieve, Cooperate, Care, and Innovate are the values that we share and practice daily.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries,
but it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on LinkedIn, Twitter, Instagram, and YouTube.
YOUR ROLE
- Coordinate the preparation and assembly of regulatory submissions for medical devices and pharmaceuticals products to ensure timely completion and filing as required in Chile affiliate.
- 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 (e.g., variations, renewals, notices, withdrawals, new registrations, etc.).
- Coordinate with the local regulatory team the proper submission documents needed during the life cycle of the products in Chile (variations, renewals, notifications, withdrawals, promotional materials, and new registrations), as well as internal corrections and import permits, when applicable.
- 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.
YOUR BACKGROUND
- 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 a 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.
We offer continued personal development. When you join Guerbet, you:
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging.
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient’s life all over the world.
- Are joining a company where we value diversity of talents coming from various horizons.
We # Innovate # Cooperate # Care # Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to *******@guerbet.com or you can also call this number +19843443717.
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▶️ Regulatory Affairs Coordinator Chile & SOLA Job Details | Laboratoire Guerbet
🖊️ Guerbet
📍 Santiago