TRABAJO REGULATORY SUBMISSIONS CRO BARCELONA, BARCELONA

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

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

As regulatory professionals working on oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments...

Prepare various official and regulatory documents for regulatory and other agencies, such as dossiers, blas, inds, safety and annual reports, handling of responses...

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...

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

Provide expert scientific input into the preparation of regulatory documents and interactions with regulatory authorities... desirable experience with regulatory...

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

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

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

The candidate will lead all regulatory submissions... is required a minimum of 7 years of relevant experience industry experience in drug development including experience...

Typical accountabilities   utilize physiologically-based pharmacokinetic (pbpk) and translational modeling tools to enable clinical pk projections for drug-drug...

• experience in clinical trial methodology, regulatory requirements, scientific methodology, statistics and writing of publications... • contributing towards responses...

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrolment, case report form (crf) completion and submission...

Responds to company, client and applicable regulatory requirements/audits/inspections... conducts remote or on-site visits to assess protocol and regulatory compliance...