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Regulatory CMC Associate Manager


  • Frissítve 777 napja
Our customer, an international pharmaceutical company with headquarters in Basel, is looking for motivated candidates to strengthen their team.


Regulatory CMC Associate Manager


Your key responsibilities include:

• Author high-quality CMC documentation for HA submission
• Assure technical congruency and regulatory compliance
• Prepare CMC responses to health authority questions during development, registration and product lifecycle
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
• Actively participate as a member of the global Reg CMC team by contributing to the regulatory strategy, identifying critical issues

Your background includes:

• Degree in Science (e.g. Pharmacy, Biology, Chemistry)
• Work experience in one of the following fields: pharmaceutical technology, biotechnology, analytics, chemistry
• Knowledge of drug development processes and of regulatory affairs is desirable
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload
• Strong planning, organizational and interpersonal skills
• Excellent communication and negotiation skills
• Fluency in English


Assignment start: asap
Planned duration: December 2014 (with chance of prolongation of the contract)
Workload: 100%

Have you already worked in a scientific field in the area of drug development and would you like to broaden your expertise in regulatory affairs? If in addition you have strong communication and organization skills you are the candidate we are looking for. Please apply online or send your complete application (CV, reference letters, diplomas) to Nicole Blum ().
Region: Basel
Vertragsart: Befristet
Kategorie: Qualitätswesen;
Naturwissenschaft/Forschung
Veröffentlicht am: 17.10.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1408-14386
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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