Regulatory Affairs Specialist Chile

hace 1 mes


Santiago, Metropolitana, Chile Guerbet A tiempo completo

At Guerbet, we build lasting relationships 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 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 on a daily basis.

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.

The successful candidate will 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.

Additionally, the Regulatory Affairs Coordinator will support in-country regulatory consultants and/or local distributors through Latin America to ensure filling of regulatory submissions to the respective regulatory bodies.

Responsibilities:

  • Coordinate the preparation and assembly of regulatory submissions for medical devices and pharmaceuticals products.
  • Support in-country regulatory consultants and/or local distributors through Latin America.
  • Be aware of the regulatory strategy of the company.
  • Manage regulatory submissions tracking process in Chile.
  • Closely supervise regulatory consultants and/or local distributors in Latin America.
  • 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.
  • Ensure that all product lifecycle information are provided to Headquarters in a timely manner.

Requirements:

  • Bachelor's degree or equivalent in health sciences, chemical pharmaceutical discipline, or related 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.

Guerbet offers continued personal development. When you join us, 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.

We #Innovate #Cooperate #Care #Achieve at Guerbet. We offer a salary range of $80,000 - $120,000 per year depending on experience.



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