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Regulatory Manager Veterinary 179008Ref: BBBH22637

Salary:£45000 - £65000 per annum + bonus and benefits

Added:12 Oct 2017

Region: South East

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

My client, a global Pharmaceutical company, is currently looking for an experienced veterinary Regulatory professional to join their team as a Regulatory Affairs Manager. Within this role you will be responsible for managing the veterinary product registration chain, compliance with regulatory authority requirements, maintenance of product authorisations/licences and relevant LCM (life cycle management) activities. Duties & Responsibilities: *Responsible for the management of product registration activities in accordance with corporate policies and strategic direction of Global Regulatory Affairs and in line with legislation required by the particular country *Maintain and update the global RA databases (e.g. WPPS, CPD3, BIRDS, TAPAs) *Manage the activities of Regulatory Affairs in order to obtain and maintain licences, renewals and changes in product registrations *Responsibility for the management of LCM activities in compliance with the existing legislation and policies, representing the regulatory needs and priorities of local business and cooperating with SBU and Global RA/R&D teams; *Develop and maintain proactive relations with the authorities responsible for regulatory affairs in the country as well as stakeholders and influencers. *Responsibility for reviewing and providing compliance guidance for promotional activities that is timely, accurate and consistent. *Management of information and regulatory dossiers in order to ensure confidentiality, information protection and agility to provide information on registration processes to relevant stakeholders. Experience/Qualifications *Educated to degree standard in a suitable scientific discipline *In depth knowledge of local and European regulatory affairs legislation and guidance *Experience in the Animal Health pharmaceutical industry working in Regulatory environment with a demonstrable network of external key stakeholders. *Strong planning and prioritisation skills *Process-oriented *Excellent communication and interpersonal skills *Analytical and detail oriented *A high level of product, technical and disease area knowledge *Ability to critically appraise scientific/clinical data *Proven ability to work as part of a multi-disciplinary team *Assertive confident credible communicator *Skilled at developing positive working relationship and influencing others For further details about this role, or to discuss other opportunities within Regulatory Affairs, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@keypeople.co.uk

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