Beschreibung

In this role, you will enhance regulatory compliance for biological products while staying updated on Swiss regulations. Your day-to-day responsibilities will involve collaborating across teams, preparing for inspections, and ensuring adherence to regulatory standards.

Anforderungen

• •Advanced degree or equivalent experience in European Life Sciences
• •Minimum 10 years of relevant pharmaceutical regulatory affairs experience
• •Knowledge of Swissmedic & European regulatory landscape
• •Well-versed on biologics CMC regulatory requirements
• •Advanced organizational skills
• •Agility in interacting with management, customers, and regulators
• •Customer-centric attitude with business sense
• •Ability to work with cross-functional teams
• •Effective verbal and written communication skills in English and German
• •Rigorous attention-to-detail skills
• •Ability to evaluate and resolve technical-regulatory issues
• •Sound skills in typical office electronic platforms
• •Adherence to OHS policies and procedures

Aufgaben

• •Enhance regulatory compliance and services for biological products
• •Monitor Swiss regulations and industry trends
• •Participate in professional trade association working groups
• •Attend congresses to stay updated on pharmaceutical regulations
• •Foster collaboration for regulatory compliance across the network
• •Define site licensing strategies and submit applications
• •Handle SMF updates and submissions
• •Prepare for and participate in regulatory inspections and audits
• •Assess regulatory impact for the Change Control process
• •Set up and optimize regulatory systems and SOPs
• •Ensure proper archiving of relevant documents
• •Translate product registration information into quality control documents
• •Perform gap analysis on product CMC information and operations
• •Collaborate on components compliance with Quality Control
• •Promote regulatory services in partnership with Sales
• •Draft quotations for regulatory services
• •Provide project regulatory liaison across multiple sites
• •Counsel on regulatory matters and strategies
• •Author and review CMC/CTD M3 quality documents
• •Assist with deficiency letters from regulatory agencies
• •Track invoices related to regulatory revenue targets
• •Ensure adherence to regional deliverables for Global Regulatory Affairs

Tools & Technologien