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Job description / Role
Job Purpose:
- Ensure the development and implementation of the regional/local strategy across MENA for the Marketing Authorisation Transfers of the affected products.
- Leads 2 regulatory specialists, supervises and contributes in all the MAH transfer and LCM regulatory related activities from submission preparation until approval of all the MAH transfers.
The role is accountable for:
- Create a strong Area team of MAH transfer and CMC experts to take over all the operational activities related to MAH transfer of the concerned products.
- Work closely with central teams of GRA or any third party, his/her team and LOC staff to ensure implementation of MAH transfer and Lifecycle management activities (variations & renewals) at the LOC level.
- Generate and consolidate periodic reports of the project status in the markets of his/her responsibility
- Ensure Area visibility at all times of database systems content, ensure data maintenance activities are performed, updates made accurately & in a timely manner (Responsible to Run regular checks on OPAL/ AGILE).
- Responsible for Pack Management: updating or creating Packaging Components according to the relevant country regulations and specificities
Requirements
- Bachelor Degree (or higher) in a scientific discipline, preferably Pharmacist.
- Solid Regional Regulatory knowledge.
- Data consolidation, collation and compilation skills, Multiple Project Mgmt skills, Clear communication skills, Fwp & Tracking abilities.
- 4 years previous experience working in an Area/Regional/Multi-market role in a reputable MNC.
- Fluent in English, Arabic and/or French written and verbal (additional languages will be considered as an added-value: Urdu, Turkish)
About the Company
The Adecco Group is the world’s leading talent advisory and solutions company. We proudly make a difference in the working lives of 3.5 million people every year. Our culture is entrepreneurial and inclusive, and we are united by our passion for making a difference in the world of work. We work with over 100,000 organizations in 60 countries, enabling their success. We have 35,000 people working with us across more than 60 countries and territories.
Adecco has been rapidly growing in the Middle East since 2008, developing a substantial footprint throughout the region. We work across 250 different clients, Adecco has more than 62 full time employees, working in 4 offices, servicing all countries across the GCC region. We offer Temporary Staffing, Permanent Placement, Executive Search, Assessments, Visa And Payroll, Outsourcing, PRO Solutions customised as per client requirements. Adecco Middle East Head Office is based in Dubai with a branch at Abu Dhabi.