Job Details

Senior Regulatory Affairs Manager

A fast growing pharmaceutical company is seeking a Senior Regulatory Affairs Manager.

This expanding and highly successful research and development company manufactures pharmaceutical prescription products.

As the Senior Regulatory Affairs Manager you will manage the Regulatory affairs department and work closely with the company\’s marketing team to prepare new drug applications and licences.

Key Responsibilities:

 Manage the Global Marketing Authorisation Application processes including planning and execution
 Support Clinical Trial Applications
 Liaise regularly with the company\’s Technical and R & D departments
 Work closely with external marketing partners and regulatory CRO\’s

The ideal candidate will have at least two years experience in Regulatory Affairs, particularly in generic pharmaceutical production. Experience of new product submission and maintenance of licenses is desirable.

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