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Job Details

Regulatory CMC Change Control Consultant

Company: MSI Group Limited
Location: Belgium
Reference: VR-9977
Closing Date: 24 Feb 18
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Freelancing role - Belgium

Requirements:

 

Our client, a globally recognised pharmaceutical company are actively looking for a CMC change control regulatory consultant to join their team in Belgium for a 12 month position.

 

CMC/Regulatory Affairs activities:

  • To liaise between the GRA organisation and Manufacturing Performance Unit on regulatory compliance matters including deviations and change controls.
  • Be the Single Point of Contact (SPOC) for any topic related to regulatory affairs.
  • Follow-up of MA (marketing authorisation) and of regulatory life-cycle activities on Nimenrix and Mencevax in Europe and Worldwide where client is still MAH. Ensures that these licences for Nimenrix and Mencevax are maintained in compliance with regulatory requirements worldwide.
  • Review and approval of all source documentation supporting CMC variations impacting Nimenrix and Mencevax.
  • Initial assessment of potential regulatory impact of changes.
  • Review and approval of eCCs impacting Nimenrix and Mencevax.
  • Liaise with Operations for the definition of implementation and release strategy.
  • To update in timely manner the clients regulatory tracking tool (OPAL)
  • Send out weekly OPAL reports to all stakeholders
  • Interaction with external partner on their regulatory tracking tool

 

Skills/Education Requirements:

  • Scientific/Engineering degree ( Chemist or biochemist)
  • Knowledge/Skills
  • Excellent understanding & knowledge of regulatory procedures / systems / guidance’s eg. Opal, CTD section (Module 3)
  • Fluent spoken and written English
  • Autonomous and results-driven
  • Proactive with ability to identify and follow up on gaps in process
  • Ability to work under pressure due to the requested flexibility and reactivity of the activities
  • Be able to manage short term issues with long term activities in parallel.
  • Ability to work in project teams in a multidisciplinary environment and a matricial organization

 

CMC, Change Control, Regulatory Affairs, MA, MAA, eCCs, Deviations, SPOC Regulatory

 

 

 

 

Apply for this job: Regulatory CMC Change Control Consultant

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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