Belgique 16.10.2020

Regulatory Affairs Manager

Tasks

We are currently looking for a Regulatory Affairs Manager to manage the content of relevant technical/CMC sections of project, to ensure proper planning and execution of regulatory submission packages worldwide and resolve supply related issues that may arise, i. e. :

  • Provide support to the supervisor for key regulatory activities pertaining to a project
  • Interact with internal project related teams for technical/ CMC and procedural aspects
  • Participate to project related discussions and provides in-depth strategic, scientific and RA input for technical/CMC and procedural aspects
  • 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 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 Product 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 as needed
  • Facilitate and deliver the regulatory strategy to support the life-cycle of the asset; contribute for technical/CMC and procedural aspects
  • Provide support to the supervisor to assure efficient interactions with the regulatory authorities to achieve on-time approvals of product 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 colleagues
  • Ensure planning and proper organization of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones 

Requirements

  • MSc. In Life science (PhD. or M. D. is a plus)
  • Knowledge of Regulatory legislation in different geographical areas
  • Understanding of biologicals/vaccines
  • Significant experience in regulatory affairs (CMC/ procedure lifecycle management), or appropriate relevant experience in the pharmaceutical industry
  • Proven ability to manage typical regulatory activities, resolve problems and deliver results.
  • Fluent in English
  • Team spirit
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SPONTANEOUS APPLICATION
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SPONTANEOUS APPLICATION








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