TRABAJO REGULATORY AFFAIRS STUDY START

Ensuring compliance with global regulatory requirements, gcp, ich guidelines, and company-specific processes for study start-up activities...

Provide specialist regulatory and technical scientific support to facilitate efficient business development, initiation and maintenance of clinical trials, whilst...

Response documents, study protocols, psrs, etc... • identify regulatory risks and propose mitigations to lead rpm and cross-functional teams...

Securities and exchange commission, applicable regulatory approvals, and satisfactory completion of financing...    responsibilities: oversee emea hazcom management...

What you will be doing: support the day-to-day operations of assigned activities within ssu to ensure completion per established goals and objectives in compliance...

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

Reports study progress/update to the global study associate director/ global study team including smm lead... collaborates with local medical affairs team...

· regulatory compliance (change control, post-approval activities, etc... )· interactions with key business partners and regulatory authorities· launch or supply...

The lab forms part of international consortia focused on advancing research in regulatory genomics, single cell genomics, and human genetics...

Manage regulatory documentation and submissions, maintaining audit readiness... our benefits! ?⏰ flexible start time from monday to friday (full-time)...

Provide expert input on study protocols and methodological strategy... stay current on regulatory and methodological developments and promote best practices...

Collaborate with medical, regulatory affairs, pharmacovigilance, and quality teams... ensure efficient budget management and regulatory compliance (gcp, fda, ema...

You enjoy collaborating with study teams, clinical sites, and regulatory bodies to ensure trials start on time and in full compliance... this role is partly office-based...

study management associate, asm/sasm (snr... monitoring plan, study specific training documents... executes regulatory agency inspection readiness activities (e...

Our global regulatory affairs team is expanding! we are looking for a regulatory affairs lead position to work for one of our key clients... this fast-growing, international...

Leads/contributes to the preparation of delegated study documents (e... informed consent form, master clinical study agreement etc), and external service provider...

Implementation of study amendment-and changes in study related processes)... as required, manages the local study supply... drive study compliance by maintaining...