وظائف ادارية لدى فيرينج للادوية في حيدرة ، الجزائر
Regulatory Affairs Specialist – Maghreb Region
Your main focus is to work within the local Health authority in Algeria to have a completed portfolio in the market and ensure product release to market according to the local regulation and global standards.
Your main responsibilities will be:
- Collects information on registration requirements in country/ region, and sets timelines for registration approvals.
- Ensures the availability and/or prepares regulatory documents and certificates necessary for obtaining registration approvals.
- Compiles and manages regulatory applications for Ferring products to health authorities, which includes new products, product dosage forms, indication. As well as registration maintenance through renewals & variations submissions.
- Provides labeling support and maintaining SPC update in the region. Reviews locally prepared labeling before approval & implementation.
- Ensures the availability and/or prepares regulatory documents and certificates for obtaining rapid approvals.
- Carry out of Regulatory submission processes and Pharmacovigilance case processing processes within agreed timelines
- Reviews promotional materials developed by the marketing department from a regulatory point of view
- Provides data to RIMS (Register) Data Entry Team.
- Builds and maintains professional relationships with regulatory authorities and industry groups, and work with local RAMs towards shaping a favorable regulatory environment for long-term business objectives
- Ensures QA Compliance (Product) according to Global QA processes, local regulations and registered specifications, including but not limited to the below activities: Shipment release & Tenders supply (from QA and regulatory perspective)
- BSc degree in pharmacy
- Experience: 3-5 years of practical experience in the regulatory field Know-how of interactions with regulatory authorities.
- Language: English, French and Arabic Languages
Location:Ferring Middle East Algeria office