Back to search.Grafton Recruitment - Pharmaceutical Licensing Manager
| Employment Type: | Permanent |
| Location: | County Down - Northern Ireland, United Kingdom |
| Salary: | £40 - £70 per annum + benefits |
| Languages: | English |
PHARMACEUTICAL LICENSING MANAGER, Newry, Excellent salary and benefits
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 role is pivotal to managing a clear strategy using knowledge of license variations to achieve required changes efficiently whilst ensuring complianceThis is an outstanding opportunity to join a world leader that has consistently generated the fastest growth in sales and profit in its sector.
This key position reporting to the Director of Licensing represents an excellent opportunity to grow your international career within an exceptionally dynamic, creative and strongly entrepreneurial environment.
Job description:
* Define regulatory strategy and interface with other internal functions to ensure continued success in new markets.
* 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 Norbrook brands.
* Lead multiple regulatory project teams
* Plan and conduct regulatory projects including management of resources, training, technology and reporting
* Provide project and administrative oversight including forecasting, budgeting and reporting
Essential criteria:
* PhD in a scientific field plus > 12 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 forUSAis 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.
* Intellectual rigour, insightfulness and sound judgement.
* Negotiation skills, oral communication skills, attention to detail, ability to multitask, adapt to changing situations and staff and project management skills
* Demonstrate strong leadership skills, working within a matrix organisation with cross functional teams. An effective team player, with a collaborative management style
please send your cv through the link
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 role is pivotal to managing a clear strategy using knowledge of license variations to achieve required changes efficiently whilst ensuring complianceThis is an outstanding opportunity to join a world leader that has consistently generated the fastest growth in sales and profit in its sector.
This key position reporting to the Director of Licensing represents an excellent opportunity to grow your international career within an exceptionally dynamic, creative and strongly entrepreneurial environment.
Job description:
* Define regulatory strategy and interface with other internal functions to ensure continued success in new markets.
* 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 Norbrook brands.
* Lead multiple regulatory project teams
* Plan and conduct regulatory projects including management of resources, training, technology and reporting
* Provide project and administrative oversight including forecasting, budgeting and reporting
Essential criteria:
* PhD in a scientific field plus > 12 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 forUSAis 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.
* Intellectual rigour, insightfulness and sound judgement.
* Negotiation skills, oral communication skills, attention to detail, ability to multitask, adapt to changing situations and staff and project management skills
* Demonstrate strong leadership skills, working within a matrix organisation with cross functional teams. An effective team player, with a collaborative management style
please send your cv through the link
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