Törzskönyvezés állások, munkák

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....

• Lead patent activities across emerging markets, with occasional global scope
• Advise regional and country leadership on patent strategies for pharmaceutical development, licensing, and launches
• Contribute to shaping the strategic direction of Abbott’s global patent team

Serve as the labeling lead for all global labeling matters, ensuring regulatory‑compliant, current, and competitive core labeling documents (CDS, BPL, BSS)....

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

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

• Drive and complete reimbursement applications for the Vibrant product portfolio
• Build and check health economic models that clearly demonstrate product value by using appropriate software tools

• Identification of patenting opportunities, drafting of patent applications and development of suitable filing strategies
• Handling of all stages of patent prosecution, including requesting SPCs/PTEs where applicable
• Supporting the Patent Conflicts Team as needed

• Serve as the primary regulatory contact for Swissmedic for assigned products
• Prepare and manage regulatory submissions for new marketing authorisations and lifecycle changes
• Develop and implement regulatory strategies for Switzerland in coordination with international teams

• Accountability to lead teams within overall CMC development project(s)
• Drive strategies and activity within the team to support overall development plan.
• Establish good working relationships with internal and external stakeholders

• Risk Identification & Assessment - Analyze risks related to product development, manufacturing, post market, useability, biocompatibility, cybersecurity, vigilance, compliance, etc..
• Implementation of Risk Controls - Develop strategies to minimize risks and improve processes.

• Drive global CMC strategies for clinical trial applications, new product licenses, and post-approval changes.
• Assess CMC, facility/equipment, and plasma-related changes and manage regulatory submissions in coordination with regional teams.

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

• Drive innovation by evaluating and continuously advancing therapies through aerosol inhalation
• Communicate scientific insights effectively and foster strong interdisciplinary collaborations to ensure successful translation into clinical practice