Regulatory Affairs Leader

Job Details

A leading Global Pharmaceutical company are presently looking to bring in a highly experienced Regulatory Affairs Leader to be based in the UK Office Blackpool Office.

Job purpose:
To effectively manage the registration of the Company's products worldwide whether new product introductions or maintenance of existing registrations whilst maintaining complete regulatory compliance throughout.


Principal Accountabilities:
To supervise the Regulatory Affairs function ensuring it fully supports the business objectives of Company CMW.
To establish and maintain good relationships with Regulatory Authorities, Regulatory colleagues at Franchise companies and distributors; and to provide support and advice to worldwide company colleagues.
To effectively manage worldwide registration activities.
To ensure product approval and registration is obtained for all new products by ensuring that all new product dossiers are created where appropriate in line with local country requirements.
To drive effective registration strategies to ensure regulatory programmes are standardised to obtain earliest possible approval.
To establish and maintain processes for the status and maintenance of registrations, interim notifications and periodic re-submissions.
To strategically work with New Product Development in the development of new products and technologies delivering first in class regulatory strategy for product commercialization.
In conjunction with other departments, ensure that the company's post marketing surveillance responsibilities are fulfilled and support vigilance activities.
To liaise as appropriate with all internal departments to provide regulatory direction, input and support.
To represent Company CMW Regulatory Department to external Regulatory Bodies and customers.
To maintain progress and developments of worldwide regulatory environments, and to address regulatory requirements as appropriate.
Implement preventative and corrective action programmes as appropriate.
To deputize regulatory activities in the absence of the Group Regulatory Affairs Manager
To follow and promote Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results and adhered to in a fair and consistent manner within the Regulatory Department.
To carry out such further tasks that may be delegated by immediate manager.


Qualifications:
A good first degree in a relevant scientific discipline, or equivalent.
Significant regulatory experience covering medical devices.
Relevant experience of drug-device combination products and/or pharmaceuticals.
Commanding knowledge of worldwide regulatory procedures, especially for medical devices.
Experience gained working in worldwide markets, and able to demonstrate proven track records of achievements
Able to demonstrate projects undertaken have been satisfactorily completed within agreed timescales.
Relevant experience to supervise a Regulatory team to ensure effective contribution and commitment of staff.
Possess computer competency in Microsoft office software, data collection and general analysis tools.