TRABAJO CLINICAL REGULATORY AFFAIRS LEAD

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

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

Persona metódica y bien organizada... participar en la mejora de los riesgos de producto, según iso , y actualización de los mismos, con los diferentes departamentos...

Supports pmda inspection clinical matters... supports jcls to develop clinical data package, design or select clinical studies constituting the clinical data package...

• lead clinical-regulatory authoring teams during the regulatory response period up through approval... • lead development of the clinical submission communication...

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...

Strong understanding of clinical trial processes, regulatory requirements, and best practices in data management and analysis...   we are currently seeking a principal...

As a subject matter authority for regulatory affairs the individual will provide guidance to local and global business partners... the regulatory affairs associate...

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

Gestión y desarrollo de equipos · asegurar el alineamiento del equipo de regulatory affairs specialists con los altos estándares y los objetivos definidos por el...

Reviews related clinical data management documents... services overview:   clinical data management expertise...     data management experience...

Consults with management personal to establish strategies and prepare appropriate regulatory filings for the regulatory activities... interacts with regulatory agency...

Are you passionate about regulatory compliance, business growth and project management? we are looking for a dynamic senior regulatory affairs specialist to lead...

lead by example... johnson & johnson is currently seeking an associate director, regulatory affairs... provide continuing regulatory education and dissemination...

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

Challenge the status quo; lead and adapt to change... experience in assembling product dossiers for submission to regulatory authorities... interface with cross-functional...

Previous experience in clinical trial regulatory submissions... knowledge of the principles, methods, and procedures of clinical research...

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

In-depth knowledge of regulatory environment, regulations and guidelines... regulatory affairs ensures that a product complies with the national health authority...

Support and coordinate the regulatory affairs activities of the company... esg & regulatory affairs manager role description (part time)velto renewables (velto)...