LAVORO MANAGER REGULATORY LIFECYCLE PROCESS

Strong knowledge of regulatory operations, including end-to-end labeling, product and lifecycle registration, dossier management, regulatory information management...

Prepares and/or reviews regulatory documents to support clinical trial submissions... independently provides regulatory support for complex projects and programs...

Able to lead process working groups... if a people manager you will: manage direct reports in regulatory medical writing... maintain and disseminate knowledge of...

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations... identify regulatory complexity and challenges and offer...

Good regulatory and\/or technical writing skills... determine regulatory strategy\/expectations and parameters for submissions and all necessary authorizations...

Should have solid understanding of the drug development process including gcp and local regulatory requirements... may represents functional area in process initiatives...

Position: we are looking for a regulatory affairs manager for an important service company operating in the regulatory field... at least 5 years of experience in...

Maintain active participation in product lifecycle management planning and associated ra execution...   experience   minimum of 6 years ’ project management experience...

Drives process qualification (pq) requirements... design and implement process improvement projects to improve product quality, cost savings and efficiency...

Good knowledge and ability to apply gcp\/ich and applicable regulatory guidelines and applicable regulatory guidelines... participate in the selection process for...

Extensive knowledge and experience in regulatory compliance and applicable regulations at eu, national and local levels...   your key tasks and responsibilities...

Role: process engineering manager scope: depuy, cork job function engineering, reporting to senior manager, make asset management (mam) part of technical operations...

) in tight connection to the product lifecycle – a capability generally referred to as simulation process and data management (spdm)... must have knowledge of simulation...

Its products enable pharmaceutical and biotech companies to continuously ensure product quality and meet regulatory standards... the candidate will report to the...

Keywords: director regulatory strategy, director regulatory strategy, cmc, senior manager regulatory strategy, cmc, cmc regulatory affairs, cmc regulatory...

Participate in industry-level regulatory events and maintain positive interactions with regulatory colleagues... partner with regional and global regulatory operations...

Ensure all process development, validation, etc... maintain and report on “in process monitoring” processes... updates and maintenance of manufacturing specifications...

Oversees the application process for clinical studies, in force in the country(ies) of work...                                       the application process    ...

        support or lead initiatives for process robustness optimization and competitiveness... job description: j&j innovative...

Contributes to process improvement... should have solid understanding of the drug development process including gcp and local regulatory requirements...