Regulatory Affairs Compliance Expert

Région
Wavre
Publication
mardi 2 octobre 2018
Date limite
vendredi 2 novembre 2018
Réf
83A92XPE-BE
Contact
Kathleen Callebaut
Fonction
Autre
Niveau d'expérience
0 à 2 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein
eXPErt services for eXPErt professionals.
That's XPE. For one of our clients we are looking for: Regulatory Affairs Compliance Expert Organisation description:

At XPE Pharma & Science you're not just a consultant, you are one of a kind.

Not only will we track down the perfect assignment for you. Our HR Talent Managers value Talent and build client-focused solutions with that in mind. They are dedicated to help you boost your career. This by coaching sessions, development centers and performance reviews.

Respect and professionalism are at the basis of our job. We are willing to go the extra mile for and with you.

Job description:

The regulatory oversight and the alignment of the Operations to the approved data by the Health

Authorities have a direct impact on the release of the lots on the markets and then on the capability

of the Belgian plant to deliver its clients.

Therefore, it is very important that you clearly understands the pharmaceutical business

as well as the compliance aspects of the job.


In that context, the principal duty of the Site Conformance, dedicated to secondary Manufacturing

Performance Units: MPU Rota and MPU Packaging, is:

1. To liaise, between the Global Regulatory Affairs organization and Manufacturing

Performance Unit, on regulatory compliance matters,

2. To ensure the regulatory oversight within operational Belgian MPU


The duties of the Site Conformance Specialist are :

1. Act as liaison between GRA and the MPUs on regulatory compliance matters in the scope of

Rota and packaging activities

2. Support within CMC processes:

o Ensure accuracy of MPUs source documents requested for filing in the time frame

required.

  • Review and Approve, on behalf of MPUs, files submitted to Health Authorities.
  • Represent the MPU at the Submission Team led by GRA.
  • Coordinate Questions & Answers and Commitments.

3. Be the Single Point of Contact (SPOC) for any topic related to regulatory compliance to

support filing

4. Change Control

  • Perform the initial assessment of the potential regulatory impact of changes.
  • Liaise with Global Regulatory Affairs for the definition of the regulatory strategy
  • Liaise with Operations for the definition of the implementation and release strategy



Profile:
  • Master/PHD
  • Pharmaceutical Sciences, Biology, Chemistry, Bio/Chemical Engineering or any other applicable scientific discipline
  • Experience inwriting CMC (technical) parts of regulatory documents (registration files or variations) for EU, US and International
  • Knowledge of regulatory procedures / systems
  • Very good level of spoken and written English
  • Experience working with Biologics (if possible preferred over Pharmaceuticals)
  • Knowledge of the EU/US variations policy
  • Experience in a research laboratory or in regulatory/drug development/public health organization


Soft skills :

You manages your own time to meet agreed short-term targets.

And you ensures the coherence between contributions / quality of final results.

Furthermore you are a real Team player



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

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