Licening Manager/ Regulatory Affairs Manager - Northern
Ireland , Supberb relocation and offer package for the ideal
My Client a leading global pharmaceutical
company are seeking to appoint a professional Licensing
Manager to deliver the regulatory and safety strategy for all
products across Global markets and to ensure on-going
The role will require the successful candidate to
deliver assigned brands to new markets with focus
on the use of regulatory knowledge to support product
This role is pivotal to managing a clear strategy using
knowledge of license variations to achieve required changes
efficiently whilst ensuring compliance and duties will include:
Define regulatory strategy and interface with other
internal functions to ensure continued success in new
Provide strategic Regulatory input to support products
at all stages of their life cycle.
Develop and implement global regulatory strategy for
your projects to ensure competitive advantage for company
Lead multiple regulatory project teams
Plan and conduct regulatory projects including
management of resources, training, technology and
Provide project and administrative oversight including
forecasting, budgeting and reporting
Preferably educated to Masters Level in a scientific field with
ideally plus 5+ 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
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
A proven ability to lead and influence colleagues successfully
in a dynamic and evolving matrix environment.
Intellectual rigour, insightfulness and sound judgement.
This is a FANTASTIC opportunity to join a
leading Worldwide Pharmaceutical Company - with outstanding
benefits and salary package.
My client will also offer an attractive relocation package for
the ideal candidate. Fluent in speaking and writing English is
essential to be considered.
Only candidates that meet the above criteria will be contacted.
If you have not heard a response within 7 days , please assume that
on this occassion your application has not been successful
Remove from Shortlist Career Architechs - 11 months ago