Regulatory Affairs Manager – Edinburgh

Barney Smith is recruiting for a Regulatory Affairs Manager to join a Contract Manufacturing Organisation based in Edinburgh on a permanent basis.

Responsibilities include managing the product license registration with regulatory authorities on a worldwide basis and managing the regulatory affairs team. You will also be expected to manage, prepare and maintain regulatory documentation to ensure compliance with quality standards and FDA Regulations.

This could be a great opportunity for you if you have significant experience in managing a Regulatory Affairs department within a diagnostic, medical device, virology or immunology related environment. As this client is experience substantial growth due to the success of their core business so this is an opportunity to join a company at an exciting time.

Click here for more information or to apply >

 

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Amgen and Astellas Announce Japanese Link

US biotechnology giant Amgen has entered a partnership with Astellas Pharma of Japan in order to provide for the medical needs of Japanese patients, reports www.chemweek.com.

A new business model, combining both companies’ capabilities has been agreed. Amgen’s pipeline candidate drugs are to be joined with Astellas’ knowledge and presence in the Japanese market. Five of Amgen’s pipeline developments, for the treatment of diseases of a cardiovascular nature as well as cancer, are set to be further commercialised and progressed.

A joint venture company will also be established, with the name Amgen Astellas BioPharma, with the intention of enabling Amgen to quickly establish a significant presence in Japan. This is expected to be set up and running by 1st October 2013.

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Regulatory Affairs Officer Job – North of England

Graeme Pallas at CK Science is currently recruiting for a Regulatory Affairs Officer to join a Medical Devices company based in the North East of England. This is a six month contract position.

Responsibilities:

  • Prepare regulatory submissions for countries that implement marketing regulations including US, Canada, Japan and China.
  • Manage creation and development of technical files.
  • Manage and maintain medical device registrations.
  • Provide regulatory input in to product development projects.

 

The ideal candidate:

To be considered for this Regulatory Affairs Officer role, you will have demonstrable experience of Quality Management Systems such as ISO13485 and ISO9001.  Ideally, you will have regulatory submission experience of 510(k) and Technical files for in-vitro medical devices.

How to apply:

For more information or to apply for this Regulatory Affairs Officer position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk. Please refer to reference 22613 in all correspondence.

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Regulatory Affairs Manager Job – North Scotland

Our client, a Scottish diagnostics company require a Regulatory Affairs Manager on a temporary basis to cover maternity leave.

Reporting to the Quality Assurance/Regulatory Affairs Director you will be responsible for a small team ensuring company activities are in compliance with regulations applicable to the diagnostics industry.

To be considered for this Regulatory Affairs Manager position, you must have the following skills and experience:

  • Have experience of working within or in close interaction with the RA team in relation to regulatory submissions or verification activities.
  • Be knowledgeable about the requirements of at least one of the following areas, IVD Directive, FDA 510k submissions, cGMP requirements as they impact on RA.
  • Have experience in interacting with external partners and regulatory agencies including the FDA.
  • Have the ability to build key relationships within the senior management team to promote and direct RA within the organisation.
  • Have supervisory experience.
  • Educated to degree level in a life science subject or have demonstrable experience in a regulatory affairs position.

 

How to apply

For more information or to apply for this Regulatory Affairs Manager position, please contact Graeme Pallas on 0191 384 8905 or email gpallas@ckscience.co.uk.

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