YOUR CONTRIBUTION
Join our motivated team in Global Regulatory Affairs and grow with exciting challenges. As Global Regulatory Lead (GRL) you are the primary interface and key strategic partner to Global Product Team (GPT) of throughout the product life cycle on New Assets and its maintenance. This will include the following activities:
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Shaping regulatory strategies and submission plans related to new registrations or life cycle management and representing regulatory requirements worldwide
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Creating high-quality documentation and carry out required registration procedures ensuring compliance and internal requirements
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Ensuring and implementation of the necessary regulatory activities for the preparation and submission of applications for new registrations in accordance with the respective national regulatory requirements (e.g. local studies)
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Leading the creation and maintenance of the Company Core Data Sheet (CCDS) for the assigned products as well as ensuring the necessary processes are followed
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Ensuring and managing the answering of inquiries from the authorities
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Implementation of necessary regulatory life cycle management activities (e.g. line extensions, annual reports, post-approval commitments, change control, renewals, import licenses, company registrations
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Leading and coordinating regulatory projects as well as communication with the respective Merz representatives, partners or consultants as key regulatory member of the assigned Global Product Team (GPT)
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Preparation and/or participation in scientific consultation with the regulatory authorities worldwide in close collaboration with the respective country RAM and other regulatory functions as appropriate
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Support in the creation of benefit dossiers or health technology assessments, price and reimbursement applications, as well as due diligence procedures as applicable
