TRABAJO REGULATORY AFFAIRS PRODUCT QUALITY

Experiencia mínima de 2-3 años en roles de quality assurance y/o regulatory affairs en la industria farmacéutica... laboratorio, ubicado en la zona de barcelona...

Escalates issues to cmc regulatory affairs management that affect registration, regulatory compliance and continued lifecycle management of the product...

The role will work on several regulatory software applications that leverage the connected regulatory intelligence platform... pharma product manager - connected...

Maintain global quality oversight, oversee global regulatory filing activities including product registration and variation management, of assigned novartis biologics...

Provides regulatory affairs support during internal and external audits... assists in the development of standard methodologies for regulatory affairs processes...

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

Represents regulatory affairs on cross-functional project teams... provide regulatory affairs support during internal and external audits...

Delivers cmc regulatory strategy to support major inspections (eg pai's) or quality incidents (pircs)... creates, maintains and continually evaluates/improves cmc...

Strong understanding of regulatory affairs globally    direct regulatory affairs cmc experience with submissions for synthetics and/or biologic and biotechnology...

This includes the resolution of regulatory issues and questions from regulatory agencies during the pre-market product development phase... provides support in preparation...

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

Apply gxp principles according to the stage of product lifecycle... our chemistry, manufacturing, and controls (cmc) regulatory function spans across the product...

Understand chemical and product regulatory compliance... generating product sds and labels... knowledge of product risk management and product stewardship is a benefit...

) and/or quality management systems (i... collaborate with product / platform roles to understand product strategy and squad projection needs... lims, sdms, etc...

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...

Person responsible for regulatory compliance (prrc)... the primary responsibility of the quality and regulatory manager is to oversee the implementation of quality...

Serves as regulatory liaison throughout product lifecycle... serves as regulatory representative to marketing, r&d teams and regulatory agencies...

quality management system implementation: lead the establishment of quality management systems (qms), including procedures, work instructions, and templates, while...