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Global Regulatory Affairs CMC - Long Temp 11 months min.

Kelly scientific is looking for a great pharmaceutical company a Global Regulatory Affairs CMC (Temporary position 11 months min.)

Job Purpose
In line with global strategies and through alignment with the CMC Manager/Lead and CMC responsible, develop and execute global CMC regulatory strategies for the assigned portfolio of projects / products.

Major Accountabilities
• Responsible for all CMC regulatory matters relating to registrations and maintenance of business activities for assigned project portfolio.
• Interacts with colleagues in other departments, other R&D functions and other Global Regulatory Affairs functions to deliver high quality dossiers, documents & materials in accordance with business priorities. Establish and maintain sound working relationships with partners and customers.
• Supports regulatory affairs teams in the affiliates for assigned projects and products including preparation of responses to Health Authority questions.
• Provides CMC evaluations for potential changes as requested and follows up to ensure regulatory compliance including completion of Trackwise records.
• Provides, in close partnership with internal/external authors, all the necessary high quality technical documents for submission for the assigned portfolio of products assuring technical congruency and regulatory compliance.
• Effectively communicates requirements and guidelines, facilitating timely and complete submissions. Applies systems and procedures necessary to maintain proper records and support adequate controls.
• Develops up-to-date knowledge with regard to guidelines & regulations, as well as technical trends.

Education : Degree in related scientific discipline
Experience: 0 to 4 years in CMC Regulatory Affairs
Mathilde Dromard, Scientific Recruitment Consultant | PhD in Biology and Health | Kelly Services (Suisse) SA, Rue du Rhône 114, 1204 Genève, Switzerland
Region: Vaud
Vertragsart: Befristet
Kategorie: Strategie & Management;
Veröffentlicht am: 23.07.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1407-12783
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" />
Munkavégzés helye Not Specified
Kategória Külföldi munka
Régió Külföld
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