Recrutement Regulatory Affairs Specialist Contractor
ALGER
- Catégories: Santé
- Wilaya: ALGER
- Publiée le: 21-09-2023 à 22:48:33
- 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).
Profil :
- ;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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