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Egypt Regulatory Specialist - MSR coordinator

  • Location
    (EGYPT) and Al Qahirah
  • Job Reference
  • Functional Area/Experience
    Health and Life Sciences / 1 Year

Job Description & Qualifications

Regulatory Specialist - MSR Coordinator is responsible for the efficient management and delivery of Market Specific Requirements. 

Key Responsibilities

  • Liaise with MSR suppliers (GMS, External Supply QA, LOCs) to obtain documentation in a timely manner.
  • Prepare the Market Specific Requirements package for regulatory submissions.
  • Ensure appropriate archival of MSR data package.
  • Organize dispatch of MSRs.
  • Update tracking systems (e.g., OPAL) with dispatch dates and D-numbers as defined by process documents.
  • Escalate changes through the relevant process.
  • In addition to above activities, if SC role is being done then following activities needs to be performed.
  • Coordinate the preparation of regulatory submissions (e.g., Renewals, Product Expansion Dossiers for Emerging Markets, Site registrations, Tenders)
  • Monitor plans for upcoming submissions
  • Check with relevant groups to understand ongoing regulatory activities that may affect the submission package, agree and document strategy.
  • Liaise with documentation suppliers to ensure components are delivered in a timely fashion.
  • Communicate availability of data package to LOC.
  • Maintain knowledge of relevant submission formats and outputs and guidance associated with different formats of regulatory submissions which may differ with each Authority.
  • Compliance checks and reformats Regulatory documents if and when required.

Education / Previous Experience Required:

  • University Bachelor’s degree in Chemistry, pharmacy or other related sciences.
  • 1 to 3 years’ experience in a similar role
  • Working experience within Regulatory Affairs

Job Skills/Competencies Required

  • Good command in English and French (written and spoken) is a must
  • Broad understanding of the pharmaceutical industry, drug development environment, and R&D processes
  • Global/ EMAP Regulatory submission experience - Knowledge of regulatory agency guidelines
  • Proven ability to work on multiple projects simultaneously
  • Ability to build effective working relationships and work in a matrix environment effectively
  • Ability to think flexibly in order to meet constantly shifting priorities and timelines.
  • Excellent communication and interpersonal skills
  • Ability to work across boundaries with high level of discipline, commitment & accountability
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