TRABAJO REGULATORY SUBMISSIONS BARCELONA, BARCELONA

Identify regulatory risks and communicate mitigations to regulatory lead and cross functional teams... review documents and provide regulatory input (e... accountabilities/responsibilities:...

Ensures best practices are shared within global regulatory... provides the mc regulatory input into eu issue management resolution...   ensures the global regulatory...

) identify regulatory risks and communicate mitigations to regulatory lead and cross functional teams... the ram is a contributor to regulatory submission strategy...

Understanding of regulatory affairs globally... define the strategy and content of international cmc submissions and review and approve regulatory cmc documents...

Professional capabilities: regulatory knowledge... strong understanding of regulatory affairs globally... direct regulatory affairs cmc experience with submissions...

What you'll do: lead cross functional teams in major regulatory submissions (nda/bla/ind/cta), health authority interactions, label discussions, and securing approvals...

Develops and builds expertise in regional regulatory requirements to ensure assurance of compliance of cmc submissions... essential skills/experience: bachelor's...

More than 10 years of regulatory affairs experience experience in global regulatory strategy and submissions that have progressed through to registration...

With access to our extensive capabilities and comprehensive pipeline, you’ll be involved in countless submissions and a wide range of engaging projects along the...

regulatory knowledge: a deep understanding of global regulatory requirements and ich/gcp guidelines... what you bring to the table: experience: at least 10 years...

Location: barcelona (on-site) job description / capsule the director, statistics has sufficient experience in the pharmaceutical industry to independently lead a...

Liaise with regulatory affairs and the broader clinical pharmacology team to align on strategy, plan for resources, and ensure timely delivery of global submissions...

The scope of work includes, but is not limited to, clinical study report development, regulatory submissions, commercialization, and the scientific utilization of...

The extensive experience in the pharmaceutical industry to independently lead a biometrics team to deliver project and/or technical level activities related to design...

Main responsibilities: demonstrate independence in providing statistical support for standard design and interpretation of study data under guidance of a more experienced...

You will apply expert skills to investigate, apply novel statistical approaches, for relevant statistical issues and/or regulatory guidance and/or value demonstration...

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