RA Manager

Région
Wavre
Publication
mercredi 8 mars 2017
Date limite
samedi 8 avril 2017
Réf
6FEE2XPE-BE
Contact
Andreea Ardelean
Fonction
Autre
Niveau d'expérience
5 à 10 ans d'expérience
Type de contrat
Fixe
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: RA Manager Organisation description:

XPE Pharma & Science is looking for a RA profile. Role will be to project manage filing of variations worldwide including Europe and resolve supply related issues as well as the management of the content of relevant technical/CMC sections of project/product specific documents submitted to regulatory agencies worldwide. It may involve both maintenance of dossiers as well as new dossier submissions. The person will be required to communicate both internally and externally, to maintain update various databases and planning tools associated with the role as well as write documents technical and procedural in nature. The position will be initially for a 12 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/product.
  • Interact with (or represents his/her area/product at) internal project related teams for technical/ CMC and procedural aspects of a given project.
  • Participate to project/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 optimise 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 asset(s) (project-specific).
  • Provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of the company submissions for the asset(s).
  • 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 technical/CMC and procedural aspects) in line with the overall project plan and RA milestones.
Profile:

Education: Ph.D. degree (preferably biological/chemical) Knowledge of Regulatory legislation in different geographical areas Understanding of biologicals/vaccines Ideally more than 6 years of experience in the pharmaceutical industry; this should include at least 3 years RA experience. Proven ability to manage typical regulatory activities, resolve problems and deliver results Good communication skills – Team spirit Able to communicate in English

Offer:

Open end contract on XPE payroll; Highly professional working environment.



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