Törzskönyvezés állások, munkák

• Acquiring and maintaining marketing authorizations.
• Creating the necessary submissions for authorizations and tracking them from the first documentation until authority decision.
• Monitoring relevant legal changes and verifying the accuracy of packaging materials and patient information leaflets.

• Gyógyszer törzskönyvezéshez kötődő feladatok, törzskönyvi dokumentációk, beadványok összeállítása angol nyelven
• A gyógyszerek életciklusa alatt a változások kezelése, módosítások támogató dokumentációjának összeállítása angol nyelven
• Eljárások koordinálása

Állatgyógyászati termékek regisztrációs dossziéjának II. részének (Part II) szerzői és szakmai elkészítése, strukturált átírása és naprakésszé tétele a hatályos EU-s és hazai előírások szerint....

Vigliance Specialist% (w/m/d)True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector sinceWe are an innovative pioneer in the field of ventilators.Hamilton Medical is a leading manufacturer of intelligent...

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Lead Expert Quality Assurance, Deputy Responsible Person 40%Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing...

CSV EngineerYou can find all of our job offers by clicking here: /.Teoxane Laboratories were established in Geneva, Switzerland, inThey are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care....

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...