Regulatory Affairs Manager

Région
Wavre
Publication
jeudi 29 novembre 2018
Date limite
samedi 29 décembre 2018
Réf
8BFBEXPE-BE
Contact
Kathleen Callebaut
Fonction
Autre
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Manager Organisation description:

As a RA manager your daily tasks will be related to the regulatory management of products (Vaccines). Your role will be to project manage filing of variations worldwide and to resolve supply related issues as well as the management of the content of relevant technical/CMC sections of project and product specific documents submitted to regulatory agencies worldwide. It may involve both maintenance of dossiers as well as new dossier submissions. you will be required to communicate both internally and externally, to maintain or update various databases and planning tools . The position will be for a six month period and would be based in Wavre, Belgium.

Job description:

The role has the following responsibilities: You will provide support to the supervisor for key regulatory activities pertaining to a project and product. Interact with or represents his internal project related teams for technical/ CMC and procedural aspects of a given project. Participate to project and product-related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects of given project. Provide in-depth input into the asset specific regulatory strategy on a global scale for technical/CMC and procedural aspects. Provide support to the supervisor via critical review of the technical and procedural section of regulatory documents Coordinate (for technical/CMC and procedural part) the determination of key messages for product/portfolio specific regulatory documents to be submitted to Authorities, in collaboration with supervisor Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements. Provide input to Vaccines Development Plans in order to optimize the label by use of appropriate regulatory procedures to secure the optimum submission strategy; contribute for technical/CMC and procedural aspects. Facilitate and deliver the regulatory strategy to support the life-cycle of the asset; contribute for technical/CMC and procedural aspects. May possibly act as the point of contact for Regulatory Agencies for assets. Provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of the Company's Vaccines submissions for the assets. Must be aware of changes in regulatory guidelines and their impact on regulatory strategy for the particular assets. 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 organization of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.

Profile:

Education: Ph.D. degree (preferably biological/chemical) Language: ENGLISH: perfect command Hard Skills: Knowledge of Regulatory legislation in different geographical areas Understanding of biologicals/vaccines Experience : Ideally more than 3 years' experience in the pharmaceutical industry; this should include at least 1 year experience in regulatory (CMC/procedural). Soft skills : Proven ability to manage typical regulatory activities, resolve problems and deliver results Good communication skills – Team spirit

Offer:

Working as a consultant for XPE Pharma & Science means that you will be a part of the Adecco group. You will be guided and be followed-up by one of our Talent Managers. While giving the best of yourself at your project you will be able to develop your soft & hard skills as well via our Talent Managers.



Licenses
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002
XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713

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