Regulatory Affairs

3 days ago


Doha, Baladīyat ad Dawḩah, Qatar Premium Solutions Consultancy Full time

Premium Solutions Consultancy is seeking a highly skilled and motivated Regulatory Affairs professional to join our team. As a Regulatory Affairs Specialist, you will be responsible for ensuring compliance with regulatory requirements and guidelines for our client projects. You will work closely with cross-functional teams to prepare and submit regulatory applications, maintain product registrations, and monitor regulatory changes.

Responsibilities

  • Prepare and submit regulatory applications, including product registrations and notifications
  • Coordinate with internal and external stakeholders to collect necessary documentation and information
  • Maintain up-to-date knowledge of relevant regulations and guidelines
  • Monitor and communicate changes in regulatory requirements that may impact our clients
  • Conduct regulatory assessments for new products and ensure compliance throughout the product lifecycle
  • Participate in regulatory agency inspections and audits
  • Collaborate with cross-functional teams to develop regulatory strategies and plans
  • Review and provide input on labeling and promotional materials to ensure compliance

Requirements

  • Bachelor's degree in a scientific or healthcare-related field
  • Minimum of 3 years of experience in regulatory affairs in the pharmaceutical, medical device, or biotechnology industry
  • Strong knowledge of local and international regulatory requirements and guidelines
  • Excellent communication and project management skills
  • Experience in preparing and submitting regulatory applications
  • Attention to detail and strong analytical skills
  • Ability to work independently and in a team environment
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