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Técnico Regulatory Affairs 1

  • Location:

    Alcalá de Henares

  • Contact:

    Fernando Martin

  • Job type:

    Permanent

  • Contact phone:

    +34 91 038 10 41

  • Industry:

    Pharmaceutical

  • Contact email:

    fernando_martin@oxfordcorp.com

Oxford Global Resources are looking for a Regulatory Affairs Specialist for a very interesting professional opportunity in Madrid.

Main functions:

  • Compile, write, review and publish registration dossiers for new product registrations by applying solid international regulatory knowledge and CMC expertise.
  • Collaborate effectively with internal partners and global clients for the maintenance of marketing authorizations of all out-licensing activities.
  • Consolidate authorized dossiers and perform regulatory activities to ensure regulatory compliance.
  • Coordinate working groups for the effective response to deficiency comments from international regulatory agencies and author response documents with support from working groups.
  • Provide regulatory support and insight to internal and external partners.
  • Collaborate with service providers and coordinate activities with internal/external
  • partners to meet regulatory objectives.
  • Maintain regulatory database on a daily basis.
  • Coach other junior regulatory specialists in the department.
  • Participate in product development activities and periodic meetings with upper management.

Qualifications:

  • Solid CMC expertise gained from international registration of new products. (Please kindly refrain from applying to this position if this requirement is not met).
  • Strong project manager (experienced in the initiation, planning, execution, control and closing of projects) with the ability to multi-task to deliver high-quality regulatory work products on time.
  • Highly efficient team player who excels in a fast-paced environment.
  • Possession of strategic outlook based on a deep understanding of the product life cycle and its relationship with regulatory affairs.
  • Organized and meticulous professional who is a self-starter and autonomous.

What we offer:

  • An exciting and fast-paced working environment with ample opportunity for professional and personal growth.
  • An opportunity to be an integral part of a growing team where an impact can be made.
  • Positive working environment based on collaboration, integrity, knowledge acquisition and knowledge sharing, transparency and effectiveness.
  • Be part of a horizontal organization that is managed based on the principles of
  • empowerment.