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Associate Director, Regulatory Affairs - HertfordshireRef: BBBH22365

Salary:£65000 - £73000 per annum + car allowance, bonus and usual benefits

Added:13 Sep 2017

Region: East Anglia

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen for an Associate Director, Regulatory Affairs to join a global pharmaceutical company based in Hertfordshire. Within this role you will oversee the submission of global submissions, ranging from CTAs through to registrations and post approval. Essential main job functions: *Manage the schedule of regulatory submission's including MAAs for innovative regulatory pathways (CP, MRP and National Procedure), variations and renewals *Prepare and submit MAAs 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 materials *Participate in the preparation and management of the regulatory budget process *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 dossiers Experience/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 equivalent For further details, please contact Tim Barratt on +44(0)1727 626 or email

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