GLOBAL REGULATORY AFFAIRS – MULTI-MARKET LABELLING COORDINATOR
ARABIC SPEAKER
Location: Cork, Ireland – Relocation is mandatory!!!
Fixed-term contract
Contingency contract: working with a global pharmaceutical company
Salary: €45k-€50k DOE
Relocation assistance: €2000 one-time relocation bonus, 2 weeks of paid accommodation in a hotel once you arrive in Cork, Ireland, and corporate care assistance
Full-time position based on a hybrid model with twice-a-week attendance in the office
Required: EU Passport
Role Summary:
As a Multi Market Labelling Coordinator within our client's Global Regulatory Affairs team, you will play a key role in coordinating and supporting the development, submission, and implementation of Multi Market Labelling (MML) across diverse international regions. The role requires native-level Arabic fluency, in addition to English, and involves direct collaboration with affiliates and regulatory partners to ensure compliant and accurate product labelling, particularly in Latin America, META, Asia Pacific, and Gulf countries.
Key Responsibilities:
1. Develop & Implement Multi-Market Labelling:
* Coordinate and support international affiliate teams in developing, approving, and implementing Multi Market Labelling across assigned markets.
1. Collaborate with Stakeholders:
* Partner with Affiliate Regulatory teams, Regional Regulatory Scientists, and external Alliance Business Partners to align on regulatory labelling requirements and strategy.
1. Prepare Regulatory Submission Packages:
* Create and provide timely, complete, and compliant labelling submission documents to support both new and revised Multi Market Labelling across supported regions.
1. Ensure Compliance & Monitoring:
* Monitor reference country labelling updates and drive the implementation of revised or new labelling, ensuring adherence to global and local regulations.
1. Process Management:
* Manage the Truth/Proof process and oversee the creation and lifecycle of new MML documents in collaboration with internal and external stakeholders.
Geographic Scope:
* Support English Multi Market Labelling for countries in:
* Latin America
* META (Middle East, Turkey, Africa)
* Asia Pacific
* Support English-Arabic Multi Market Labelling specifically for Gulf countries, including Saudi Arabia, UAE, Kuwait, Qatar, Bahrain, and Oman.
Qualifications and Requirements:
1. Language Proficiency:
* Native or equivalent fluency in Arabic (written and spoken) is required.
* Full professional proficiency in English (written and spoken).
1. Education:
* Bachelor’s degree in a scientific or health sciences discipline (e.g., Pharmacy, Life Sciences, Regulatory Affairs).
1. Skills & Competencies:
* Strong cross-functional collaboration and stakeholder management skills.
* Ability to influence and communicate effectively across diverse global teams.
* Project management experience, with proven ability to handle complex initiatives under tight timelines.
* High attention to detail and strong organisational skills.
* Ability to manage multiple priorities independently while working effectively in team settings.
* Strong problem-solving capabilities and adaptability in a dynamic regulatory environment.
* Proficiency in standard business and regulatory tools and systems (e.g., Microsoft Office, Veeva Vault, regulatory databases).
#J-18808-Ljbffr