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New Opportunities

New Opportunities

Pharmaceuticals - Regulatory Affairs Manager

QUALIFICATIONS

We are looking for a “Regulatory Affairs Manager” for one of the leading companies in pharmaceuticals industry.

Qualifications:
  • University degree in related departments
  • Minimum 7-8 years of Regulatory Affairs experience in industry
  • Minimum 2 years of team management experience
  • Preferably experience in Middle East (ME), CIS, US &EU countries regulations
  • Fluency in English, both oral and written communications
  • Expert knowledge of national legislation and regulations relating to medicinal products
  • Computer skills (MS Office programs)
  • Building relationships with regulatory authorities
  • Defining and implementing policies, procedures and SOP’s
  • Advanced negotiation, collaboration, persuasion, communication and relationship building skills
  • Team Leadership skills
  • Strong analytical mind and problem solving skills
  • Result oriented and proactive
  • Multi-task oriented and ability to work with cross-functional teams

JOB DESCRIPTION

Job Description:
  • Managing whole Regulatory process including Technical, Operational and Artwork processes
  • Developing, implementing and maintaining processes and policies to meet Regulatory components of legislation and company needs
  • Obtaining and maintaining product licenses
  • Being the primary point of contact for regulatory authorities in company
  • Give Regulatory expertise to all projects which need to follow regulations
  • Preparing Regulatory Affairs plans, budget and timetables
  • Ensuring the necessary documentation and supporting local audits

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