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Regulatory Affairs Specialist

Maadi, Cairo

Regulatory Affairs Specialist

Maadi, Cairo
Posted 22 days ago
63Applicants for4 open positions
  • 17Viewed
  • 0In Consideration
  • 2Not Selected

Job Details

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Job Description

As a Regulatory Affairs Specialist at our leading regulatory affairs consultancy company, your role will be crucial in providing expert guidance and support to clients in navigating the complex landscape of regulatory compliance and approvals. You will work closely with clients from various industries, ensuring their products and services meet all relevant regulatory requirements. By leveraging your expertise in regulatory affairs, you will play a vital role in facilitating successful market entry and product compliance.

Job Requirements


  1. Regulatory Compliance: Stay updated with regulatory guidelines, laws, and standards across relevant industries (e.g., pharmaceuticals, medical devices, food, cosmetics, etc.). Assess and interpret regulatory requirements to determine their impact on clients' products or services.
  2. Product Registration and Approval: Prepare and submit regulatory applications, including but not limited to product registrations, licenses, certifications, and approvals, to regulatory authorities. Ensure compliance with applicable regulations throughout the submission process.
  3. Documentation and Recordkeeping: Create, review, and maintain regulatory documentation, such as technical files, dossiers, and labeling. Maintain accurate records of regulatory submissions, correspondence, and approvals.
  4. Regulatory Strategy Development: Collaborate with clients to develop regulatory strategies aligned with their business objectives. Advise on the most efficient and compliant paths for product development, registration, and market entry.
  5. Risk Assessment and Mitigation: Conduct risk assessments to identify potential regulatory hurdles and challenges. Develop strategies and action plans to mitigate risks and resolve regulatory issues proactively.
  6. Regulatory Intelligence: Monitor and analyze changes in regulatory requirements, guidelines, and trends. Provide regular updates and recommendations to clients, ensuring they stay informed and compliant with evolving regulatory landscapes.
  7. Cross-functional Collaboration: Work closely with internal teams, including research and development, quality assurance, and legal departments, to ensure regulatory compliance is integrated into the product lifecycle. Collaborate with regulatory authorities and third-party organizations on behalf of clients as required.
  8. Training and Education: Conduct internal training sessions to enhance the organization's regulatory knowledge and capabilities. Provide guidance and mentorship to junior team members.

Qualifications and Skills

  • Bachelor's degree in a scientific or related field (e.g., biology, chemistry, pharmacy, engineering, etc.). Advanced degrees or certifications in regulatory affairs are desirable.
  • Minimum of 2-3 years of experience as a Regulatory Affairs Specialist, preferably within a consultancy or regulatory affairs firm.
  • Preference for familiarity with Saudi regulations.
  • In-depth knowledge of relevant regulations and guidelines (e.g., FDA, EMA, ISO, ICH, etc.) pertaining to different industries.
  • Strong understanding of regulatory processes, including product registration, submissions, and compliance.
  • Excellent analytical skills with the ability to interpret and apply complex regulatory information.
  • Effective communication skills, both written and verbal, to interact with clients, regulatory authorities, and internal stakeholders.
  • Detail-oriented mindset with a strong commitment to accuracy and quality.
  • Ability to work independently and manage multiple projects simultaneously.
  • Proficiency in using regulatory databases, document management systems, and software tools.

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