Job Description

Roles & Responsibilities

Job purpose:

As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.

Job Responsibilities:

Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
Manage Performance Excellence through collection, analyzing & disseminating relevant information to team(s) as appropriate
Participate in local regulatory process improvements initiatives
Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
Ensure delivery of right first time label source text for artwork creation
Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
Access the translation agency systems to request the label translation and track the job readiness and timelines.
Perform regional prescribing information translation review: 100% review of both content and format
Perform the role of source text owner/approver and artwork reviewer/approver in the system
Trigger the existing label revision when alerted by global RA team.
Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.

Qualifications:

Experience +2 years in Regulatory Affairs
Current/ previous experience in working as part of an MNC employer
Pharmacist, biologist, chemist-medical background
Fluent in English and Arabic for translation review purpose ( French is a huge plus)
A minimum knowledge of Middle East Africa regulatory requirements
Strong communication skills (verbal & written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
Conflict Management skillset & ability to deal with multiple stakeholders simultaneously.

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