LAVORO REGULATORY AFFAIRS CONSULTANT LIFECYCLE

Base regulatory strategy recommendations on precedents and other regulatory    intelligence as well as regulations and guidelines...   minimum requirements/qualifications:...

Experience required: around 3 years' experience in regulatory affairs education: master's degree languages: english fluent technical skills... time management...

Costituirà aspetto preferenziale la conoscenza sottomissione e gestione lifecycle asmfs in formato ctd (ectd)... per un’importante società italiana specializzata...

In addition, the consultant will also contribute to business development through the development of proposals... in some cities with physical eversana offices, the...

The consultant will be involved in identifying client needs and problems and implementing robust strategic and data driven solutions while managing own workload...

Ensure alignment with clinical needs and regulatory requirements... you will operate with a high degree of autonomy within a structured commercial framework collaborating...

Document lessons learned and recommendations for continuous improvement of environmental safeguards throughout the lifecycle of the project... org/english/opportunities/job-opportunities/what-we-offer/pages/individual-contractor-agreements...

Ensure cpms maintain compliance with internal sops, gcp, and regulatory standards... strong knowledge of ich-gcp, clinical trial lifecycle, regulatory requirements...

Testing & documentation: write unit/integration tests and maintain clear technical and regulatory documentation as per medical software development lifecycle standards...

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

Prepare and present national pricing & reimbursement (p&r;) dossiers, coordinating input from medical affairs, regulatory and marketing teams...