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Regional Regulatory Hub Coordinator 2622-1

Location
Sandwich, Kent
Job Type
Contract
Posted
1 Sep 2022
SRG are currently looking for a Regional Regulatory Hub Co-ordinator for a Global Pharmaceutical Company who have opened a new vacancy within their Regulatory Affairs team on an initial 23 Month basis to be based at their offices in Sandwich/Tadworth/Remote (Hybrid). The Role: To ensure continuous supply to patients across the Eurasian Economic Union by ensuring alignment of registrations across the member states. This role supports the EAEU dossier harmonisation activities, to ensure clarity and alignment in strategy, drive the collation and dispatch of fit for purpose dossiers in line with business need. Ensures progress of activities via strong relationships to achieve aligned project deliverables. Key Responsibilities: Ensure uncompromised compliance and embrace corporate culture. Support EAEU dossier harmonisation activities in alignment and partnership with key stakeholders. Closely collaborate with EAEU regional regulatory hub strategist to ensure alignment. Ensures timely communication of any issues. Actively manage and track project timelines and deliverables. Support planning and monitoring activities, update timelines and communicate changes. Liaise with manufacturing sites for obtaining supporting documents as needed. Support right first-time approvals - review submission packages for completeness as needed. Maintain systems and databases per internal SOPs and policies. Ensure training completion as per the assigned curriculum. Skills/Experience Required: Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life science. Prior experience in the pharmaceutical industry in Regulatory Affairs, Conformance or Compliance. Experience in regulatory affairs, preferably in human medicines - minimum 3 years of experience. Knowledge of European submission and product lifecycle management processes. Demonstrated experience of proactive and effective delivery in a matrix environment. Project Management beneficial. Strong regulatory, quality and compliance mindset. Sound knowledge of the European regulatory environment. Good knowledge of CTD Module 3 and respective lifecycle processes. Good communication skills to operate in a multinational + cross functional environment. Project management skills to drive and track progress with an understanding of stakeholder needs. Team Player. If you are interested in this role or would like to have a confidential career discussion regarding other Clinical Opportunities. Please contact me: (url removed) or +(phone number removed)
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Details

  • Job Reference: 701354676-2
  • Date Posted: 1 September 2022
  • Recruiter: SRG
    SRG
  • Location: Sandwich, Kent
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Contract