Regulatory Affairs Specialist

Job Description

Responsible for supporting the preparation submission and maintenance of marketing authorizations for assigned products under the supervision of the Country Lead / Associate Director Regulatory Affairs. Ensures compliance with applicable regulatory requirements manages labeling and artwork activities supports cross-functional teams and maintains effective relationships with internal and external stakeholders.

Key Responsibilities

Regulatory Submissions and Maintenance

• Prepare and submit new marketing authorization applications for assigned products.
• Manage lifecycle activities for approved products including variations renewals PSURs and supplemental applications.
• Track product registrations and major new indications in coordination with relevant internal and external stakeholders.

Compliance and Documentation

• Ensure timely preparation and maintenance of product information including SmPCs patient leaflets physician circulars and packaging materials in line with Company and local requirements.
• Support implementation of prescribing information and other regulatory updates within required timelines.
• Maintain accurate and complete regulatory files archives and databases.
• Contribute to SOP development and implementation of updated regulatory requirements.

Labeling and Artwork

• Review translations QRD checks and linguistic quality of labeling documents.
• Coordinate artwork preparation proofing and updates in accordance with artwork management procedures.
• Ensure correct use of internal systems for artwork generation submissions approvals and record keeping.

Regulatory Intelligence and Stakeholder Management

• Monitor local and regional regulatory changes and communicate relevant updates.
• Collect and share regulatory intelligence with key stakeholders.
• Maintain strong working relationships with internal teams and external authorities.
• Participate in regulatory industry groups and internal workstreams as assigned.

Qualifications and Experience

• . in Pharmacy or another Life Science discipline required.
• Minimum 2 years experience in the pharmaceutical industry preferably in regulatory affairs medical or laboratory roles.

• Strong written and verbal communication skills.
• Excellent organization planning and attention to detail.
• Ability to manage multiple priorities and work under pressure.
• Strong teamwork and independent working capability.
• Proficiency in Arabic and English.

Required Skills:

Preferred Skills:

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