Regulatory Affairs Specialist Contractor
Publication date: Sep 29, 2021
- Function: Hospitals / Pharmaceuticals
- Nb position: 1
- Types of contracts:
Fixed term contract
- Academic level: > bachelor level +5
- Experience: 3 to 4 years
- For assigned products, ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities.
- Secures for assigned authorized products timely submission and follow-up of variations, renewal applications, and supplemental marketing authorizations.
- For assigned products ensures timely, accurate and compliant labeling translations and artwork preparation.
- Ensures permanent compliance to local regulatory requirements and to comapany’s policies and procedures.
- Demonstrates clear leadership in shaping the regulatory environment to support Subsidiary’s objectives.
- Collects relevant public available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
- For assigned products and tasks, works alongside the BD, locally, regionally and globally, to support business initiatives.
- Ensures commercial shipments release by sending appropriate documents to distributors in a timely manner.
- Liaises with different stakeholders (manufacturing sites, distributorsetc.) and ensures release dossier conformity to HAs requirements.
- Coordinates labeling activities and Collaborates closely with Registration Managers in order to ensure timely submission.
- Ensures updates to all regulatory databases.
- Supports local business with promotional materials and events review and submission.
- Works in cross-functionality with local departments: Supply, Market Access, Business, Medical Finance, etc.
- Maintains a positive relationship with internal and external regulatory contacts.
- Ensures permanent compliance to local regulatory requirements and to internal policies and procedures.
- Ensures administrative support to the Regulatory Department with internal and external stakeholders (Finance Department, vendors ..etc).
- Pharmacy University Degree.
- +3 Experience in pharmaceutical industry.
- +2 years relevant regulatory affairs experience.
- Excellent command of both French and Arabic.
- Fluent in English.
- Excellent organizational skills.
- Strong communication skills and ability to persuade stakeholders.
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