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An established industry player is seeking a Senior Manager for Corporate Regulatory Affairs to lead regulatory strategies across multiple sites. This pivotal role involves ensuring compliance with regulatory standards and providing expert guidance to local teams on CMC development and regulatory submissions. The ideal candidate will possess a Ph.D. in Chemistry or Pharmacy and bring extensive experience in regulatory affairs, along with strong leadership and communication skills. Join a forward-thinking organization where your expertise will contribute to the successful development of innovative products in a collaborative environment.
As part of our growth strategy and succession planning, we offer a new challenge a Senior Manager Corporate Regulatory Affairs at our site in Bubendorf, Switzerland. You will be a member of the Corporate Quality Organization responsible for Regulatory Affairs & CMC. You will elaborate and maintain the corporate RAC development standard in cooperation with the local regulatory affairs and CMC teams of the three Business Units (Drug Products; Drug Substance and Biologics & ADCs); Specialties for in total 8 sites and monitor its compliant execution. You act as a Business Process Owner for the corporate regulatory affairs systems like the e-submission software and the monitoring of the applicable regulation and guidelines. You provide regulatory affairs advise and hands-on support for local regulatory affairs internal improvement- and customer projects as required.
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Requirements:
For further information please contact the Human Resources department.