Description
JOB OUTLINEPreparation and submission of regulatory dossiers for new MAA's, variations (CMC and clinical) and renewals.
Provision of regulatory support and documentation to partnering companies.
Regulatory manufacturing compliance activities including review of change controls, maintenance of compliance dossiers, notices of regulatory approval etc.
Review and approval of product artworks.
Review and approval of raw material / finished product / packaging material specifications and other controlled documents for compliance with the MAs.
Support to the Regulatory department, including archiving of regulatory dossiers and correspondence.
Maintenance of tracking databases in relation to the status of ongoing regulatory activities.
Skills and Experience
A MSc in a life sciences discipline.
Minimum of 3 years work experience in post-marketing Regulatory Affairs in a pharmaceutical company or European regulatory authority.
Strong computer and administrative skills.
Excellent verbal and written communication skills.
Prior work experience with eCTD publishing software.