Chile_Technical Manager

Job description

Celltrion Group provides biosimilar and innovative biopharmaceutical medications to help increase patient access to advanced therapies around the world. Celltrion Group offers biologics to about 110 countries, along with more than 30 global partners around the world. With hands-on experience and knowledge accumulated through years of working in the advanced pharmaceutical markets around the world, Celltrion Group has been securing distribution channels and providing patients with biosimilars at affordable prices. Ensure the registration of all new products within the prescribed period. Renew the Sanitary Registration of all products marketed by the company and prepare and maintain their registrations before they expire. Prepare all necessary documents for successful product registration in a timely manner. Maintain and coordinate with contracted laboratories or agencies. Coordinate quality assurance and control actions. Responsible for issuing Good Storage Practices (GSP) and Good Distribution and Transportation Practices (GDTP) certificates, as well as maintenance certificates. Cooperate with colleagues in the preparation, management, and supervision of all processes required in the public bidding process to achieve legal and technical authorization. Ensure that all documents related to product licensing and registration are up-to-date with customs before pharmaceutical importation, act as an inspector of pharmaceutical products during importation, and approve product storage conditions and local labeling before distribution. Oversee and/or coordinate the import process. Serve as the safety and complaints officer and report all quality control issues to the Management Committee. Review all marketing materials prior to promotion to comply with local policies on advertising and promotion of registered products. Ensure that the local regulatory authority and third parties have been informed in a timely and accurate manner about safety issues related to the company's products and can therefore act appropriately to safeguard the interests of patients and healthcare professionals while complying with legal/regulatory requirements related to monitoring and reporting adverse events. Provide basic training in pharmacovigilance, pharmacology, and pharmacokinetics of the product to company employees. Handle medical information inquiries from internal and external customers and healthcare providers. Act as a conduit for information on new research developments, clinical trial activities, and therapeutic approaches, thereby involving presenting information to the pharmaceutical product teams to promote new therapeutic products to physicians and other healthcare professionals. Responsible for the company's Pharmacovigilance.