Job Title: Medical Regulatory Affairs Specialist

Location: Cairo

Department: Regulatory Affairs

Reports To: Regulatory Affairs Manager

Job Summary:

The Regulatory Affairs Specialist is responsible for ensuring compliance with all regulatory requirements for pharmaceutical, medical devices, or related products. This role involves preparing and submitting documentation to regulatory agencies, monitoring regulatory changes, and collaborating with cross-functional teams to ensure product compliance.

Key Responsibilities:

• Prepare and submit registration dossiers for new products and variations to the relevant authorities.
• Keep abreast of local, regional, and international regulatory changes and ensure compliance with applicable laws and regulations.
• Maintain accurate records of regulatory submissions and communications with regulatory agencies.
• Work closely with Quality Assurance, and Marketing teams to ensure that product development aligns with regulatory requirements.
• Conduct risk assessments and provide guidance on regulatory implications of product changes.
• Provide regulatory training and support to internal teams as needed.
• Participate in internal and external audits related to regulatory compliance.

Qualifications:

• Education: Bachelor’s degree in Pharmacy, or a related field
• Experience: Minimum of 2-3 years of experience in regulatory affairs within the pharmaceutical or medical device industry.
• Knowledge: Strong understanding of local and international regulations (e.g., EDA, WHO standards).
• Skills:
• Excellent written and verbal communication skills.
• Strong analytical and problem-solving abilities.
• Proficient in Microsoft Office Suite and regulatory submission software.
  

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