CHE-106.649.671 Fisher Clinical Services GmbH
Manufacturing Planner(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
Lengnau
CH
CHE-106.649.671 Fisher Clinical Services GmbH4 Tage
Regulatory Affairs Manager(m/w/x)
Vollzeit
mit Homeoffice
Senior
Keine Angabe
5426 Lengnau
Nejo KI-Zusammenfassung
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.
Lass KI die perfekten Jobs für dich finden!
Lade deinen CV hoch und die Nejo-KI findet passende Stellenangebote für dich.
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
Master-Abschluss
Berufserfahrung
10 Jahre
Deine 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
cGMPGMPEMAFDAICH
Sprachen
Englisch – verhandlungssicher
Deutsch – verhandlungssicher
Die Originalanzeige dieses Stellenangebotes in der aktuellsten Version findest du hier. Nejo hat diesen Job automatisch von der Website des Unternehmens CHE-106.649.671 Fisher Clinical Services GmbH erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Ähnliche Jobs direkt in deine Inbox?
Noch nicht perfekt?