LAVORO REGULATORY CERTIFICATION ENGINEER PARMA, EMILIA ROMAGNA

Who we are looking for purpose the global regulatory lead contributes to the company’s success by managing the corporate r&d pipeline (projects in r&d development)...

Ensure project deliverables adhere to regulatory guidelines and quality standards... experience required minimum of 7 years experience in regulatory affairs...

Support qualified persons in the preparation and sending requested documents to regulatory authorities (aifa) for new implementation or inspection follow-up...

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, global technical development, drug delivery...

To oversee signal and risk management activities for chiesi products to ensure patient safety and compliance with global regulatory and quality standards...

Provide updates at the different research committees and senior management, prepare research reports and peer-reviewed manuscripts, and contribute to the preparation...

Processes and tools     support the implementation and specific adaptation of procedures within rwe studies fulfil regulatory requirements and company strategic...

Collaborate with other functions both locally and at corporate level (other production sites/affiliates), also interfacing with r&d, regulatory functions and external...

Advanced excel skills are required in-depth understanding of the pharmaceutical industry, including market dynamics, regulatory environment, and patient treatment...

) languages fluent english (both written and spoken) technical skills     sound competences in pharmaceutical technologies as pmdi (preferred) / sterile products/...