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Regulatory Affairs Registration Manager

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Ellen Claes
Recruiter



Ellen Claes
Recruiter
0499752248


Description de l'emploi

Purpose of the Mission (project & department description)

The Regulatory Affairs Registration Manager is responsible for the maintenance of the worldwide vaccine licences. by ensuring the planning/dispatch/submission/follow-up/approval of data-packages due to Regulatory Authorities: Variations, Commitments, Questions & Answers, PSURs/PBRERs, Risk Management Plans (RMPs), Renewals, Articles 46, Updated files, WHO Annual Reports, New Dossier requests etc …

Primary Tasks & Responsibilities

The role has the following responsibilities:

  • Coordinate and interact with the internal stakeholders (labeling/safety/epidemiology/clinical and technical Experts) for the preparation of the documents part of the regulatory dossiers/data-packages in order to meet the submission timelines
  • Ensure that all regulatory aspects on the product safety/Pharmaco-vigilance and commitments/obligations to Authorities are closely monitored and fulfilled
  • Prepare cover letters, application forms, letters of intent, letters to request deadline extensions etc. Strong involvement in CTD Module 1
  • Exhibit a very good understanding and ensure alignment with regulatory legislation/guidelines, particularly relating to administrative and procedural aspects
  • Coordinate, prioritize and plan all the registration activities for the projects within area of responsibility to ensure deadlines are met
  • Maintain close contacts with the Local Operating Compagnes’s (LOC’s) to ensure shared objectives are achieved
  • Ensure the tracking of relevant correspondence with Authorities and the Local Operating Companies (LOCs): in archiving database (TRAC-IT)

Communicate with relevant parties:

  • Communicate with external regulators on specific enquiries
  • Communicate regulatory updated information to internal stakeholders
  • Participate in (or lead) the development of the SOPs and guidelines, be trained, be a good relay to develop the awareness within the team, act sometimes as a trainer and follow Company procedures appropriately
  • Participate in (or lead) the Regulatory Project Team and gives feedback on their specific areas of expertise
  • Be responsible for Vaccine Registration activities of one or several projects
  • Identify key issues on registration activities that could prevent achieving objectives and pro-actively propose solutions

Profil

Knowledge/skills

  • Knowledge of Regulatory legislation in at least one geographic area
  • Basic understanding of biologicals/vaccines

Soft skills

  • Team spirit, flexibility and accountability, very well organized, good relationships, able to work in multi-cultural and multi-disciplinary environment, discipline
  • Integrity
  • Analytical capacity
  • Good organizational skills
  • Flexible work approach; enjoys a varied working day
  • Teamwork and collaboration
  • Customer oriented
  • Can work under stress and to deadlines
  • An eye for detail

Experience

  • Experience in the pharmaceutical industry; this should also include RA experience

Education, Methodology & Certification Requirements

  • University degree (preferably biological/chemical), advanced degree is often preferred.

ICT Skills (software, operating systems, hardware, etc.)

  • Microsoft Word
  • PowerPoint
  • Excel

Language Proficiency Requirements

  • English - Fluent

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Coordonnées de contact

Formation et expérience

Nombre d'années d'expérience*
0499752248