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Global Regulatory Manager
Eingestellt von Harvey Nash IT Recruitment Belgium
Gesuchte Skills: Support, Marketing
Projektbeschreibung
One of our clients, an international company in the pharmaceutical industry currently requires a Global Regulatory Manager
Start: 20/10/2014
Length: min 12 months
Location: South of Brussels
Job Purpose
The purpose of the job is to:
* Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
* Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q contribute for clinical/labelling and/ortechnical/NC and/or procedural aspects.
* Facilitate and deliver the regulatory strategy to support the life cycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
* May possibly act as the point of contact for Regulatory Agencies forasset(s) (project-specific)
* Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of submissions for the asset(s)
* In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her expertise area(clinical/labelling and/or technical/NC and/or procedural).
* Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
* Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
* Ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.
Tags: Regulatory Affairs, affaires réglementaires, RA, Pharmaceutical, pharmaceutique, life sciences, clinical, labelling
Start: 20/10/2014
Length: min 12 months
Location: South of Brussels
Job Purpose
The purpose of the job is to:
* Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
* Determine from a strategic and scientific perspective the content of relevant sections (technical/non-clinical (NC), clinical/labelling or procedural) of project/product specific documents submitted to regulatory agencies worldwide (eg. MAA/BLA, variations/sBLA, Q contribute for clinical/labelling and/ortechnical/NC and/or procedural aspects.
* Facilitate and deliver the regulatory strategy to support the life cycle of the asset; contribute for clinical/labelling and/or technical/NC and/or procedural aspects
* May possibly act as the point of contact for Regulatory Agencies forasset(s) (project-specific)
* Provide support to the GRL to assure efficient interactions with the regulatory authorities to achieve on-time approvals of submissions for the asset(s)
* In collaboration with the relevant RA functions, as appropriate, escalate gaps in resources to ensure the execution of the agreed RA plan to the GRL, within the remits of his/her expertise area(clinical/labelling and/or technical/NC and/or procedural).
* Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular asset(s).
* Develop and motivate collaborators (within RA team or for one of the RA aspects with multidisciplinary teams) to achieve quality output, accountability and recognition across the organization and towards the regulatory authorities.
* Ensure planning and proper organisation of activities (for one of RA specific activities within clinical/labelling or technical/NC or procedural) in line with the overall project plan and RA milestones.
Tags: Regulatory Affairs, affaires réglementaires, RA, Pharmaceutical, pharmaceutique, life sciences, clinical, labelling
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Marketing/Vertrieb, Sonstiges