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Innovation
Consulting

Regulatory Affairs Expert APAC 702

We are looking for an RA Expert to contribute to regulatory activities performed on the RA Platform. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions, interaction with health authorities on behalf of PLG customers

About us

Group 13
Required technical skills:

 

  • Ability to input with Consultancy level expertise for the APAC region on a multitude of topics
  • APAC lifecycle maintenance experience
  • Providing support during external and unannounced audits.
  • Responding to internal requests for technical and/or regulatory information.
  • Preparation and submission of documentation for post-approval applications including variations, renewals, safety updates MAH Transfers/Change of Ownership
  • Preparation and submission of Technical/Site Transfer Applications
  • Proficient with the preparation of Marketing Authorisation Applications for the APAC region
  • Monitor and maintain up-to-date knowledge of APAC guidelines and legislation.
  • Ensuring compliance with all regulatory processes, in readiness for both internal and external audits.
  • Proficient in the use of a variety of software packages to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data eg Microsoft Office Suite, Veeva (or comparable EDMS), LorenZ, Trackwise etc
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget

Additional Skills

 

    • Previous Line Management experience/desire to move in to Line Management would be an advantage
    • Previous experience in a consultancy environment would be an advantage
    • Experience of promotional/non-promotional activities would be an advantage
    • Excellent IT skills/knowledge
    • Excellent organisational skills
    • Excellent communication skills
    • Pro-active attitude and able to work on own initiative as well as part of a team
    • Ability to prioritize different workloads/multi-task
    • Personal responsibility for ensuring a high standard of work

Regulatory Affairs Expert APAC 702

Apply