Digital experience manager állások Külföldön (törzskönyvezés)

• Provide support to complete product dossiers, technical files and responses to information requests
• Coordinate and complete documents required by federal agencies, incl. maintaining complex files and electronic document management systems
• Work with project teams to obtain approval for company products

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

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)...

Definition and implementation of the clinical evaluation strategy for complex and challenging development projects focused on innovative microsurgical applications in the area of intra-operative visualization and digital imaging in neurosurgery...

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

• 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

• 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.

Execution of consulting projects with a focus on developing market access and dossier strategies, including preparation of corresponding workshops, and participation in oral hearings with relevant authorities...

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