Dirección
forma de trabajo We are looking for dedicated individuals to join our Global Regulatory Affairs team and contribute to developing our superlative pipeline of drugs and biologics into innovative therapies for our patients worldwide. And it all starts with you. Your interest, your talent, your initiative.
As Regulatory Affairs Technician you will ensure a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements.
You will be responsible for the compliance to the requirements from regulatory agencies and maintains the technical and non-technical documentation change system. You will also assure procedures are in place to classify and maintain records and interpret and enforce all documentation formatting, standards, policies, and operating procedure requirements.
Major accountabilities:
•Preparing registration documentation for Health Authorities and customers ensuring that it follows the applicable regulations of each country. As well as ensuring consistency between and across the different elements of the registration document to be sent to Health Authorities and/or clients. Not to forget considering previous commitments with the Health Authorities in reference to the new registration document to be submitted.
• Evaluating in regulatory terms of the changes proposed by the company.
• Actively participating in new company projects that require your involvement, along with supporting the Registration Units (DRC/MRC/CO-DRA) of Sandoz and external customers by answering technical registration questions.
• Participating in any relevant working group at Novartis company group level, together with collaborating with direct supervisor, and other departments.
• Establishing good internal and external communication channels and ensure communication is effective.
• Ensuring the execution of assigned tasks according to assigned deadlines. In addition to immediately communicating to the direct supervisor the non-conformities detected in the procedures and any other incident that must be communicated and open the corresponding deviation when applicable.
• Reporting periodically to your direct supervisor the defined indicators related to the products under your responsibility to be able to report to the Global DRA API/AI function.
• Ensuring the correct status and update of registration documentation required to be reviewed in inspections by health authorities, corporate and customers, not to forget ensuring proper archiving of product documentation under your responsibility.
