TRABAJO GLOBAL REGULATORY AFFAIRS CLINICAL

/ with clinical study for japan... reporting relationships: japan regulatory affairs: sr manager, japan ra ta leader / director, japan ra ta-group leader global:...

The senior regulatory affairs specialist combines knowledge of scientific, regulatory and business issues to assist in ensuring that advertising and promotion activities...

Key responsibilities: participate in global regulatory team meetings and provide advice the applicable regulatory requirements, project-specific regulatory issues...

Prepares and/or reviews regulatory documents to support clinical trial submissions... independently provides regulatory support for complex projects and programs...

The jobholder represents regulatory affairs on the oncology solid tumors therapeutic area strategy team (tast) and on the global oncology reg affairs leadership...

Working knowledge of good clinical practice (gcp) and regulatory compliance guidelines for clinical trials... develop and execute clinical strategies...

On behalf of the senior global clinical operations program director (sr gpd), the gpd provides strategic operational leadership and oversight of a suite of global...

Assists in the development of regulatory affairs processes... regulatory affairs program lead will help robotics & digital solutions reach us and international regulatory...

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

Provides regulatory input to clinical development programs, risk/benefit assessments, and medical affairs programs... global regulatory experience is required for...

Provides regulatory affairs support for internal and external audits... communicates relevant technical and regulatory information to global partners to obtain local...

International regulatory knowledge desirable e... skills & requirements: minimum 8 years’ experience in a similar regulatory affairs role... key areas of accountability/responsibility:...

They are looking for a clinical affairs program manager europe... as part of the global clinical affairs team, you will be responsible for developing strategies...

Requirements   possess an understanding of the regulatory affairs and pharmacovigilance processes for both pre-marketed and post-marketed stages of a product selling...

Conduct training for junior regulatory affairs staff... communicate effectively with customers and respond to franchise business needs in the regulatory submission...

With our expertise, we interpret, anticipate, and shape global health authority expectations to build insightful cmc and device regulatory strategies...

• experience working within a global organization with complex geographical and organizational contexts... this will likely cover multiple regions and also link...

Good knowledge of international cmc regulatory legislation... ensure compliance with global regulatory requirements and contribute to the development of internal...

regulatory monitoring: stay informed on legislative and regulatory updates impacting global clinical operations and update sops accordingly...

Essential functions:evaluate the current structure of the regulatory affairs and how it interacts with the qms and qa in generalalign the qa approach with the regulatory...