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The Senior Manager, Medical Writing will collaborate with project teams on the development of clinical pharmacology (main area of focus) and other clinical regulatory documents in...
The regulatory Affairs Regional manager is responsible for supporting the regulatory activities related to all pharmaceutical products across the EMEA region, including SIP...
The Regulatory Affairs Associate Manager will report to and support the Regulatory Affairs Director/Associate Director by leading the preparation and submissions of regulatory...
Plan and manage local regulatory submissions to Swissmedic in compliance with corporate standards and local legal requirements. Maintain existing product registrations (variations,...
Managing a team of RA Associates that are responsible for compiling and maintaining the CMC part (modules 2 and 3) of medicinal product dossiers for the worldwide registrations of...
Take the lead in the preparation of documents to support scientific meetings with the authorities. Write, edit, and review of essential regulatory documents in compliance with all...
Work with the appropriate electronic systems soon after a new safety and indication/efficacy information becomes available or the content of the CCDS may change. When approved,...
The Director of Regulatory Affairs-International based in Basel, Switzerland will have the opportunity to lead the regulatory strategy for the assigned projects in collaboration...
Planning and coordination of relevant activities required for medical device conformity assessment under Regulation (EU) 2017/745. Compilation and maintenance of technical...
The Head of Global Regulatory Strategy is responsible for providing strategic regulatory leadership to the assigned Sobi portfolio. This includes the development of global...
As a global function leader, the Head of Regulatory Affairs for Santen CGT leads all aspects of the regulatory strategy for assigned programs in cell & gene therapy. Develop the...
Responsible for defining regulatory strategies and submissions in support of new and existing marketing authorizations for products for one or more business units/countries....
Successfully oversee and monitor CRAs in a matrix environment with a focus on quality and timely deliverables; address issues with appropriate team and line manager; direct...