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The Opportunity
The role serves as the strategic lead and final gatekeeper for all product labeling across the region. You will oversee the end-to-end "makeup" lifecycle—from initial planning and bottom-up creation to the final authorization of Arabic and English components. By ensuring every package meets both Roche’s global standards and local Health Authority requirements, you play a critical role in the safe and timely delivery of medicines to patients.
Main Responsibilities
-Setting the strategies for Planning & Tracking of labeling projects/activities in collaboration with the regional makeup team and countries in scope of the Middle East makeup.
- Support new launches, regulatory changes, and safety updates through finally authorizing and releasing a set of customization for each product that is build-to-fit for the specific needs of countries in scope.
- Create – in collaboration with the regional makeup team- whole new makeups, bottom-up, specifically tailored based on approved medical and regulatory product usage, and as accepted by local health authorities in assigned countries.
- Responsible for the final product release to patients, from makeup quality perspectives. Considered as the final safeguard in the makeup creation process, to meet all criteria of regulatory and quality compliance, as defined by the organizational standards and the regulatory and quality requirements in countries served by the released makeup.
- Organize submission packages and compilation of different labeling documents (new versions, track changes, annotated labels, comparison tables ...)
- Affiliate coordination and alignment whenever needed to ensure all-time compliant process with fastest deliverables and execution of new techniques.
- Ensure that decisions taken for labeling are accurately captured and communicated to appropriate stakeholders so that local and regional submission activities can be triggered in a timely manner.
- Provide support to Middle East health authorities queries whenever related to ME labeling.
- Ensure regulatory and product quality compliance & process improvement, within whole regulatory and quality processes, identifies gaps and ensure adherence to ME countries regulations and labeling process KPIs are in place and that Roche systems are always updated with labeling data.
- Although responsibility is shared with the rest of the team for the final product released, yet the role has special focus and accountability on the final delivered Arabic component of it.
Who You Are
- You hold a University degree in Pharmacy.
- You have a minimum of 5 – 7 years of relevant work experience in Regulatory affairs and in managing packaging labels and artworks of pharmaceutical products
- You have a strong experience in and understanding of labelling or makeup related requirements and activities.
- You are native Arabic speaker with a professional level of applying Medical/Pharmaceutical terminology in Arabic language. And an ability to understand and interpret English medical terms and reflect them into the Arabic medical language.
- You have a strong attention to details with the ability to meticulously review and edit large numbers of documents, with no margin of error.
- You are proactive and have a strong sense of responsibility
- You have strong communication and presentation skills
- You have strong stakeholder management skills
NOTE: The role is a contractor through a third party agency - renewable 1 year contract
Where pay transparency applies, details are provided based on the primary posting location. For this role, the primary location is Lebanon. If you are interested in additional locations where the role may be available, we will provide the relevant compensation details later in the hiring process.
A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Let’s build a healthier future, together.
Roche is an Equal Opportunity Employer.