TRABAJO REGULATORY AFFAIRS ASSOCIATE CLINICAL BARCELONA, BARCELONA

Organizes regulatory information, logs and tracking... maintains regulatory files/database and chronologies in good order... participate in the product development...

• represent clinical regulatory writing on cross-functional teams and advocate and train teams in authoring and review best practice... the clinical regulatory writing...

clinical research or medical experience... support regulatory team in preparing documents for study submissions...   you will build and maintain relationships with...

Product realization (without responsibility for clinical aspects, usability, and pms)... asphalion is growing and we are looking for a regulatory affairs – medical...

Desirable relevant clinical or biomedical ph... the clinical scientist is the link between the project team and all external clinical research for the program...

Extensive knowledge of clinical research regulatory requirements (incl ich-gcp) and demonstrated abilities in clinical study management processes and clinical/drug...

Strong understanding of regulatory requirements and guidelines for clinical trials, including ich-gcp and local regulatory requirements... in addition to your competitive...

The role holder will transform real-world clinical data into concrete insights for clinical development using statistical methods and innovative data visualizations...

Collaborating in global initiatives to standardize processes within and across countries (collaboration with other local and global csas) assist with local language...

regulatory reports, health authority responses and the safety content of marketing authorisation applications... your ability to work collaboratively will facilitate...

Our cardiovascular, renal and metabolism (cvrm) pipeline includes investigational therapies in varied stages of clinical development, from recently approved products...

Experience in managing external service providers and knowledge of quality standards and regulatory requirements... monitor implementation of the quality plan and...

Prepare regulatory documentation and design processes with the quality and regulatory affairs teams to comply with the artificial intelligence regulation and other...

Pre-process process and analyze data from clinical trials including demographic clinical and device usability data... prepare regulatory documentation and design...

Pharmacovigilance), clinical research, or regulatory affairs solid knowledge in drug safety related processes (incl... supports all clinical trial activity and post...

Conditions: duration:  1 year hours per day:  full time location:  barcelona focus areas:    opportunities across different teams such as research & development...

Pricing centre of excellence collaborate closely with market access & government affairs teams to build evidence that helps optimize pricing and market access on...

· participate in external and internal audits and regulatory authorities' inspections... · participate in the preparation and conduct of suppliers' audits and clinical...

Good clinical practice principles... you will develop specifications to ensure that statistical programming elements align with the overall deliverable and adhere...