Regulatory Affairs Specialist MSD

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.