München - Associate Manager Regulatory Affairs

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  - 5+ years of experience in Regulatory Affairs or other relevant industry experience- Degree in a scientific field is preferred- Demonstrates an ability and desire to manage the performance of more junior level individuals- Demonstrated excellence in managing multiple projects- May act as a mentor to junior employees Essential Duties and Job Functions: - Responsible for preparing regulatory submissions which require interactions with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures. - Responsible for submissions which may include safety reports, variations, amendments, supplements, license renewals to clinical trial applications (e.g. IND, CTAs), and marketing authorizations, original, marketing authorization applications. - Provides regulatory expertise to labeling changes and to submission teams on specified projects and topics. - Provides input to senior Regulatory Affairs professionals in the preparation of country specific labeling. - May be responsible for ensuring product packaging and associated information is updated and maintained in accordance with the product licenses. - Participate in group meetings a ...

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