Regulatory Affairs Specialist

Key Responsibilities

• 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

• B.Sc. 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.

B.Sc. 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.