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RA Regulatory affairs Registration Manager

Experis | Multiple regions | Permanent, Full-time

Published on Jobat.be 14 days ago

RA Regulatory affairs Registration Manager

Job description

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 (labelling/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/Pharmacovigilance and commitments/obligations to Authorities are closely monitored and fullfilled

· 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 ansure 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 Local Operating Companies (LOCs):

o 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.

Profile

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.

Offer

Our offer :

  • You will sign a permanent contract
  • You will receive several extra-legal benefits (company car, group and hospital insurance, lunch allowance,...)
  • You will benefit from a personalized follow-up (training, follow-up of your career plan,...)
  • You will work in a dynamic and challenging environment

More info

Experis Belgium
Matthieu De Clercq
32 2 639 10 70

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    14 days left to apply

    Characteristics

    • Function type: Administration and support
    • Sector: Chemistry and Pharmacie
    • Western Flanders
    • Eastern Flanders
    • Antwerp
    • Limburg
    • Flemish Brabant
    • Brussels
    • Walloon Brabant
    • Luxembourg
    • Liège
    • Namur
    • Hainaut
    • All jobs via Experis

    Requirements

    • Master (University or Higher Education Long Type)

    Offer

    • Permanent
    • Full-time

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