TRABAJO REGULATORY LEAD

Drive knowledge management by sharing case studies/lessons learned from regulatory activities within the regulatory science & execution...

External core interactions with: regulatory authorities, cros, consultants, partners... champions use of expedited regulatory pathways globally to accelerate patients’...

As a regulatory affairs lead ukraine, you are part of the turgan cluster and report to a regulatory affairs head... you will also be in charge of planning of regulatory...

Comply with good clinical practices (gcps), applicable regulatory guidelines, sops, policies, and, where available, cdm guidance documents...

Refines regulatory strategies as new data become available... escalates issues to cmc regulatory affairs management that affect registration, regulatory compliance...

May lead key business improvement initiatives...   participate and /or lead due diligence teams as necessary...   where necessary lead cmc related interactions with...

Collaborate with global regulatory teams and the global regulatory affairs (gra) function/teams to facilitate regulatory activities... the associate director, regulatory...

The director will lead key, strategic cmc regulatory activities for investigational and/or early commercial biological products... 7 + years of direct cmc regulatory...

The director will lead key, strategic cmc regulatory activities for investigational and early commercial biological products... creates, maintains and continually...

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...

Collaborate with global cross-functional teams and the global regulatory affairs (gra) function/teams to facilitate regulatory activities... minimum 5 years of pharmaceutical...

Provide ap regulatory affairs insights to drive regulatory policy approaches and strategies... 2 years in regulatory affairs or policy solid understanding of the...

Global regulatory experience is required for the grl role... the director, global regulatory leader, is responsible for global regulatory strategies for select projects...

Monitor and track legislation, regulatory development and the external environment, including proactively researching policies impacting bat regulatory agenda...

Generate appropriate regulatory reports based on assessment, communicate with business partners globally, and respond to regulatory authority requests...

This includes the preparation of regulatory documentation for submission to regulatory authorities (e... this includes the resolution of regulatory issues and questions...

Strong understanding of global regulatory requirements and guidelines... proven track record of successful regulatory submissions and approvals...

Working knowledge of regulatory guidelines (e... accountable to the statistical programming portfolio lead for assigned programming activities and responsibilities...

Inspections prepares the team and hosts regulatory inspections with clinical scope... key responsibilities lead remediation & integration the manager, clinical quality...

Experience leading regulatory audits and managing audit responses... act as the responsible party during regulatory audits... meticulous, with a focus on precision...