JO-1201-241485
regulatory affairs officer Regulatory regulatory affairs specialist regulatory affairs officer dublin regulator affairs advisor regulatory affairs
Dublin North Louth Ulster
Negotiable
10 - and more..
Permanent Full-time
See Description
Linda Dunne
ldunne@thornshaw.com
My client is looking to appoint a professional of the highest calibre to deliver the regulatory and safety strategy for all products across Global markets and to ensure ongoing compliance.
The role will require the successful candidate to deliver assigned brands to new markets with maximum competitive advantage focusing on the use of regulatory knowledge to support product registration.
Within a cross-functional team this role focuses on preparing high quality documentation to ensure ongoing compliance and maintenance of assigned products.
This is an outstanding opportunity to join a world leader that has consistently generated the fastest growth in sales and profit in its sector.
Qualifications/Experience:
PhD in a scientific field plus > 10 years relevant regulatory experience, including at least 5 years managerial experience
In-depth experience in pharmaceutical regulatory affairs with knowledge of investigational and marketed products, including EMA and FDA liaison experience
Knowledge of medical products and veterinary medicinal products, devices, biologics, biosimilars, generics, OTC products is desirable
Experience authoring and reviewing CMC, Effectiveness and Safety regulatory submission documents
Experience in co-ordinating Centralised, Decentralised and Mutual Recognition applications for Europe and NADA and ANADAs for USA is essential
Experience of Regulatory Affairs across all stages of Development and Life Cycle Management.
Strong credentials with the MHRA and EMEA.
A combination of scientific strength and strong commercial acumen.
A proven ability to lead and influence colleagues successfully in a dynamic and evolving matrix environment.
For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.
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