Beschreibung
* Prepare and/or coordinate preparation of high quality labelling documentation (CTD documents) for initial dossier submissions in the EU.* Support preparation of high quality labelling documentation (CTD documents) in non-EU countries.
* Provide labelling support in all registration procedures and renewals in cooperation with other relevant departments
* Manage the interaction with DRA colleagues in country organizations (COs) and with Company agents where no CO exists with regard to labelling related topics
* Support implementation of prompt and complete responses to regulatory labelling relevant queries from various stakeholders (e.g. Health Authorities, COs).
* Support defining and implementing regulatory strategy for above-mentioned activities through participation in Global Program Regulatory Sub-Teams.
* Support regulatory compliance activities, including entering product specific attributes as provided by program team representative into compliance database.
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