MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
MSD is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Today, we’re doubling down on this goal. Our Research Labs are a true scientific research facility of tomorrow, and will take MSD’s leading discovery capabilities and world-class small molecule and biologics R&D expertise to create breakthrough science that radically changes the way we approach serious diseases.
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• Handles E2E leaflet updates for Middle east shared packs as per labeling guidelines and SOPS.
• Assists in compilation and submission of leaflet update packages to the local agents in countries.
• Handles all middle-east artwork changes and ensure completion on time according to relevant Artwork Management procedures/SOPs and supporting regulatory activities timelines.
• Support local activities needed for all technical revisions kicked off by the manufacturing division.
• Ensures that all labeling databases and systems (Orion/RIM/AMS Blue/trackers & archiving) are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Adequately supports other functions as applicable to enable compliance in areas related to Labeling.
• Ensures the correct and proper utilization of the artwork system to generate mockup and production artworks.
• Ensures timely submissions on leaflet updates in ME countries before set deadline and as per current SOPs.
• Facilitate and handling shipments blockage for markets where labeling input is required to allow the release.
• Codes management.
• Works with the manufacturing division, Hub, local and global customer service to manage E2E Implementation process as per set guidelines.
• Assists in department administrative tasks, such as managing invoicing, meeting arrangements, coordinate agendas, take and circulate minutes, travel arrangements, as applicable.
• Contributes in other regulatory tasks, as required.
Qualifications
The incumbent must hold B.Sc in pharmacy or other life sciences, fresh graduates are welcomed to apply. The incumbent must demonstrate basic medical and scientific understanding and knowledge. The incumbent should demonstrate basic skills and knowledge of local and regional medicines legislation and regulatory procedures. The incumbent must have the ability to plan and prioritize regulatory tasks to meet MSD and local objectives. The incumbent must demonstrate good interpersonal and managerial skills, capability of problem resolution and the ability to work in a team environment. Commitment, dedication to quality and the ability to handle multiple priorities simultaneously is a key condition. The incumbent must demonstrate proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database applications, and internet.
Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.
If you need an accommodation for the application process please email us at staffingaadar@MSD.com.
Job: Regulatory Affairs Liaison
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Employee Status: Regular
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Number of Openings: 1
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Company Trade Name: MSD
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