Description
Responsibilities:Support New Product Development Projects as well as lifecycle management
Ensuring that the company's products comply with the regulations of government agencies.
Keeping abreast of international legislation, guidelines and customer practices.
Developing and writing clear arguments and explanations for new product licenses and license renewals.
Preparing submissions of license variations and renewals.
Working with specialist computer software and resources.
Writing clear, accessible product labels and patient information leaflets.
Resolving complex issues as they arise.
Preparing and coordinating documentation.
Maintaining quality systems.
Reviewing company practices and providing advice on changes to systems.
Specifying storage, labelling and packaging requirements.
Requirements:
Proven expertise of Pharmaceutical Regulatory Affairs on an international basis.
Business development skill sets with exposure to or having worked in a regulatory consultancy model.
Creative and innovative, embraces the new.
Demonstrate consequential thinking.
Excellent attention to detail.
Degree or equivalent in a Life Science.
Excellent communicator, both verbal and written.
Excellent command of English. German is considered an asset
Michael Bailey International is acting as an Employment Business in relation to this vacancy.