Regulatory Affairs Manager

Key People Limited
40,000 - 60,000
07 Oct 2017
05 Nov 2017
Contract Type
Full Time
Reporting into the Head of Regulatory Affairs, within this role you will be responsible for the registration of new products and the maintenance of existing products.Essential main job functions:• Manage the regulatory submissions including Marketing Authorisation Applications for innovative regulatory pathways (Centralised Procedure, Mutual Recognized Procedure or National requirements), Variations and Renewals.• Prepare and submit Marketing Authorisation dossiers in Europe and Rest of the World• Responsible for the regulatory management of medical devices (Europe and Rest of the World) either for manufacturer or distributor• Establish key contacts within the various Health Authorities • Responsible for creating, updating, reviewing and approving product information (leaflets, labels, boxes, SPCs etc.) and promotional materialsAdditional Requirements:• Management of the CMC activities with in line with pharmaceutical development, maintenance and strategy• Maintain a strong working relationship with the medical/pharmacovigilance and marketing/ commercial teams • Contribute to the implementation of the regulatory strategies for new product• Manage regulatory intelligence• Involvement with reimbursement/pricing dossiersExperience/qualifications required: • Excellent communication skills • Ability to build relationships with key stakeholders both internally and externally in order to obtain quick approvals • Able to work independently, with moderate supervision on multiple projects and within multi-disciplinary teams• Previous experience of regulatory requirements for launching a new product• Second European language ideal but not essential• Educated to degree level or equivalentFor further details about this role, please contact Tim Barratt on +44(0)1727 817 626 or email