LAVORO REGULATORY AFFAIRS CONSULTANT CRO

Il candidato ideale ha una laurea in discipline scientifiche ed esperienza in ruoli di regulatory affairs di almeno 4 anni, maturata in aziende farmaceutiche...

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

Establish a medical monitoring plan with the selected cro for the assigned studies... ability to interact with academic and regulatory experts with confidence,...

Ability to interact with academic and regulatory experts with confidence, integrity and persuasion... establish a medical monitoring plan with the selected cro for...

It is divided into integrated functional areas focusing on pipeline projects including discovery and preclinical research, chemical manufacturing and controls, drug...

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

years of clinical research experience in biopharma or cro 4+ years of clinical project management wit regional or global scope demonstrated project management...

Partnering with clinical affairs, other laminar personnel, and cro partners to develop effective communication strategies... communication and collaboration: excellent...

Years of clinical research experience in biopharma or cro... act as a subject matter expert for sponsor inspections by regulatory agencies or during audits...

Who we are looking for main responsibilities will be responsible for conducting comprehensive reviews of adverse event reports for investigational and post-marketed...

Collects, reviews, and monitors required regulatory documentation for study start-up, study maintenance and study close-out... works in partnership internally with...

Plan and conduct monitoring site visits (site qualification visit, site initiation visit, interim monitoring visit, or close-out visit) and regulatory submissions...

Key activities to be executed/supported will be: o assist pricing platform management: data load and user activation, pricing newsletter editing, ticket management...

cro management experience required at least 5-year experience on inhalation products and/or biological drug products education master degree or phd in chemistry...