东莞招聘

大型药企集团招募 市场授权转移项目-项目管理职位

要求：完整的项目管理经验，有过项目协调，推动，全盘管理的经验

擅长跨部门沟通，和法务，财务，销售，供应链等部门密切联系

对接海外国家，英文流利

制药相关背景

A Transfer of Marketing Authorisation (MA) is the procedure by which the MA is transferred from the currently approved Marketing Authorisation Holder (MAH) to a new MAH which is a different person/legal entity.

Such a Transfer may result from the MAH's commercial decision to divest the MA or be needed in anticipation of the MAH ceasing to exist as a legal entity and MA being taken over by another legal entity.

In case a MA Transfer is sought for several medicinal products, an application must be submitted for each MA (i.e. 1 application per product).

A change of name and/or address of the MAH is not a MA Transfer if the holder remains the same person/legal entity. Such change should be notified through a Type IAIN, A.1 variation application.

A Transfer of MA does not include a Transfer of Orphan designation since this is subject to a different procedure (See also “Do I also have to transfer the Orphan designation when my medicinal product has been granted such a designation?”).

A Transfer of a MA can only be initiated once a MA has been granted. In case there is a need to change the proposed MAH during the initial Marketing Authorisation Application procedure, the applicant who initially applied for the MA is advised to contact the Agency.

From this point onward:

The MAH of the MA to be transferred is termed the Transferor.

The person/legal entity to whom the Transfer is to be granted is termed the Transferee.

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