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RA Program Manager

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Kelly scientific looking for a great company localised in the Western part of Switzerland a Regulatory Affairs Manager
You will join the Regulatory and Scientific Affairs, Research & Development department of the company.
As a Program Manager, you will be responsible to develop related strategies and plans, maintain the systems and processes required for effective communication with regulatory authorities on a global basis. You will be required to provide regulatory leadership to cross-functional teams in order to compile and maintain dossiers submitted to the competent authorities.
Specifically you will:
• You will be accountable for the successful compilation of regulatory dossiers for products platforms/projects in compliance with applicable regulatory and scientific standards.
• Contribute to the development, review and reporting of complex CMC, non-clinical and clinical assessment projects for products to ensure successful marketing authorization.
• Develop plans and related projects scope, schedules and resource estimates as required for the management of the regulatory program(s).
• Support establishing and guide a small team of scientists to ensure timely and effective submissions/applications to regulatory authorities in support of the products program(s).
• Manage 3rd party / external relationships with consultant organizations as required to support the registration activities.
• Effectively manage relationships with other functions in the company and interact with competent authorities to ensure company applications are strategically aligned with regulators expectations.
• Participate in internal company cross-functional teams to provide directions and information regarding regulatory requirements and submission status in the relevant markets.

• Master's degree in Regulatory Affairs (or equivalent), PhD Graduate in a medical field (Pharmacy , clinical pharmacology).
• Broad working experience in regulatory affairs with direct experience dealing with regulatory authorities for successful new product applications and post-marketing changes.
• Work experience at a managerial level and a record of effectively leading teams.
• Good knowledge of GMP as well as GCP and pharmacovigilance is an asset.
• Action and customer oriented.
• Excellent interpersonal and communication skills and comfort with high service level expectations.
• Fluency in both written and spoken French and English, German is an asset.
Contact : Mathilde DROMARD
Kelly scientific Geneva

Region: Suisse romande
Vertragsart: Dauerhaft
Kategorie: Strategie & Management;
Veröffentlicht am: 11.04.14
Beschäftigungsart: Vollzeit (100%)
Job Nummer: JO-1308-1829
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" />
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