Associate Director of Regulatory Affairs

Reference:

Job Type: Permanent
Location: United Kingdom, Manchester,
Salary: Competitive

Start Date: March 2012

Key Tasks:

Direct and prepare regulatory submissions as required for global approvals for IVD's, including preparation of reports and interaction with regulatory officials as required.
Review product labelling and promotional literature for regulatory compliance
Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies
Interface with regulatory agencies for inquries and issues
Review R&D protocols and technical reports and other company documentds (including labelling and marketing materials when applicable) for use in regulatory submissions and in response to queries from regulatory authorities
Oversee and direct the preparation of regulatory documentation for country-specific registrations
Develop regulatory process SOPs relevant for registration of IVD products or other regulatory aspects

Applications are handled online where you will be able to upload your CV.