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Regulatory Affairs Specialist - Zürich

  • A hirdetés 1239 napja lejárt
Our customer is a specialty pharma company in the greater Zurich area in Switzerland. On behalf of our customer we are recruiting a reliable:

Regulatory Affairs Specialist (m/f)
It's a temporary contract for 7 months


• Providing, updating and managing artworks and mock-ups for submission and production.
• Coordination and organization for change management with third party vendors, affiliates and partners
• Liaison and relationship management with third party vendors, affiliates and partners
• Interfacing with internal stakeholders to plan and to ensure artworks are able to support business needs in different markets
• Manage Regulatory Affairs documentation
• Ensure traceability of Regulatory Affairs history documents (archiving, database)
• Work with teams to plan and execute smooth approval of variations
• Provide input to Regulatory Affairs Management for process improvement initiatives
• Support in worldwide regulatory activities through compilation of registration and production compliant packaging materials
• Responsibilities regarding and handling of PSUR according internal procedures

Experience/Qualifications required:

• 3-5 years of relevant experience in Regulatory Affairs
• Understanding of EU, US and international regulations related to labeling
• Good technical knowledge of pharmaceutical packaging, experience in change management of artwork, broad knowledge of Regulatory Affairs and all relevant guidelines
• Fluent in English and German, any additional languages are an advantage
• Solution oriented work approach
• Creative and cross-functional thinking
• Ability to work independently, flexibly and under pressure

Are you interested in this career opportunity? Do you want to work in a challenging position in a dynamic and innovative environment? Please apply online today!

For any further information please contact Kristine Rutishauser (Tel: (0)). Please send your application to .
Region: Zürich
Vertragsart: Befristet
Kategorie: Recht;
Veröffentlicht am: 28.08.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1408-14539
Abteilung: Kelly Services, Inc. in Switzerland is a leader in providing innovative workforce solutions. Kelly offers a comprehensive array of custom-designed outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and permanent basis. Kelly provides employment to more than 200 people in over 40 branches and specialist department throughout Switzerland.

Kelly specializes in providing professional/technical workforce solutions, with local expertise. These solutions include Finance, Science, and Medical. Kelly has a rich history in developing our solutions to address the workforce challenges of these communities, with expert staff dedicated to providing integrity and technical competency to ensure high performance, and proven results from its specialty talent.Link megjelenítése" width="0" height="0" />
Helyek Külföld
Kategória Külföldi munka
Aktiválás időpontja 2014.10.24.
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