Regulatory Coordinator

Sobi

Employer Active

Posted on 16 Sep

Experience

2 - 7 Years

Job Location

Cairo - Egypt

Education

Bachelor of Technology/Engineering(Agriculture)

Nationality

Any Nationality

Gender

Not Mentioned

Vacancy

1 Vacancy

Job Description

Roles & Responsibilities

Responsibilities:

  • Prepare and manage Marketing Authorisation Applications (MAA) for Sobi products in GCC Region, including submission to Health Authorities via national or centralised procedures.
  • Assess and process variations, renewals, and CMC changes for products and manufacturing sites across GCC/ME region, ensuring compliance with regulatory requirements.
  • Maintain up-to-date product files and regulatory documentation, including labels and leaflets, to meet internal and external requirements.
  • Monitor and report on regulatory activities, including significant changes in the regulatory environment, and prepare monthly reports.
  • Optimise approval timelines by effectively managing file evaluations and liaising with Health Authorities.
  • Ensure compliance with national legislation, international and local regulatory guidelines, and internal requirements whilst optimising company resources.
  • Provide regulatory advice and support to internal stakeholders, ensuring quality standards are met and submissions adhere to strict deadlines.
  • Perform additional Regulatory Affairs duties as requested by the manager.

Desired Candidate Profile

Required Qualifications:

  • Bachelor's degree in pharmacy
  • Minimum of 2 years' experience in Regulatory Affairs within pharmaceutical companies
  • Familiarity with SFDA guidelines and regulatory requirements in GCC countries
  • Experience managing variations, renewals, labelling updates, and other LCM submissions
  • Strong written and spoken English skills
  • Ability to handle multiple projects and adapt to changing regulatory requirements
  • Excellent soft skills and presentation abilities

Desired Qualifications:

  • GCC and/or Middle East working experience
  • Arabic language proficiency
  • Knowledge of Health Authority requirements in Middle East countries

Company Industry

  • Pharma
  • Biotech
  • Clinical Research

Department / Functional Area

  • R&D
  • Research & Development

Keywords

  • Regulatory Coordinator

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Sobi

At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients.

Here at Sobi, our mission and culture get us excited to come to work every day, but here are a few more reasons to join our team:

  • Competitive compensation for your work
  • Emphasis on work/life balance
  • Collaborative and team-oriented environment
  • Opportunities for professional growth
  • Diversity and Inclusion
  • Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments

Read More

https://jobs.smartrecruiters.com/Sobi/744000081969214-regulatory-coordinator-