TRABAJO REGULATORY AFFAIRS LEAD STUDY BARCELONA, BARCELONA

Position: regulatory affairs management director (rad), regulatory science & execution, global regulatory affairs location: barcelona - spain (3 days working from...

The role holder will contribute and lead the regulatory cmc components of business-related projects... it's through our creative ideas that we uncover innovative...

We are looking for an it solution design expert to join our regulatory affairs team... 10+ years of experience in it technology development experience, preferably...

Experience in regulatory affairs business processes is a plus (e... we are looking for an experienced individual in global drug development regulatory affairs to...

Develop and maintain relevant study plans (e... clinical study protocol (csp) through to clinical study report (csr)) in accordance with relevant az sops...

Accountabilities • support global study director (gsd) / global study associate director (gsad) and global study managers (gsms) by completing delegated study...

• supports the study lead (gsad, gsd) with developing and maintaining relevant study documents/plans (e... ) • perform study lead activities for less-complex studies...

Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence providing guidance and support to study teams...

Rwe medical lead grade: l3... lead the local upskilling of rwe with global initiatives, events and learning opportunities, coordinated with the global upskilling...

Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs...   participate in cross-functional...

You will work closely with study implementation teams, as well as clinical operations, data management and regulatory affairs to ensure the solutions meet the requirements...

Excellent understanding of clinical study management including monitoring, study drug handling and data management... supporting/participating in regular qc checks...

Represent the clinical study team at the clinical sub team... liaising with other functions to design external expert consultations, contribute to the development...

For associate director role, experience of program design knowledge of the technical and regulatory requirements related to the role leadership capabilities to be...

Project management skills to lead cross functional teams... ensure that internal and external legal and regulatory guidelines are followed and implemented...

This is what you will do: the associate director, biostatistics has sufficient experience working as a statistician in the pharmaceutical industry to independently...

regulatory reports, health authority responses and the safety content of marketing authorisation applications... you will apply your strong pv, oncology and scientific...

Pharmacovigilance), clinical research, or regulatory affairs solid knowledge in drug safety related processes (incl... reports events or reactions as required by...