Consultant
Areen Chemical Industries
Total des années d'expérience :23 years, 11 Mois
I am currently working as a consultant for Areen Chemical Industries where I am responsible for creating procedures & SOPs for all functions within the company including creating SOPs, job descriptions and everything related to proper management of the company.
Looking after all Drug Regulatory Affairs matters for all Novartis items (more than 500 SKUs from different divisions of Novartis - Novartis Pharma Services, Novartis Consumer Health, Sandoz & Novartis Vaccines).
Major Responsibilities
1. Heading a Drug Regulatory Affairs Team consisting of 4 team members (DRA Manager, DRA Officer, DRA Coordinator & DRA Associate).
2. Work on building and maintaining strong business relationship with the Health Authorities.
3. Work on improving distributor's RA performance related to all Novartis products (Novartis Pharma, Novartis Consumer Health, Sandoz & Novartis vaccines): (time and quality of submission/approval).
4. Prepare registration file (tailored to the country requirements) and provide Table of Content to ensure proper controlling and tracking of the submitted documents.
5. Responsible for all pricing issues related to all Novartis items.
6. Provide registration status and data required by local marketing and business
7. Align with local management concerning maintenance of the existing Novartis portfolio (variations, renewals, pricing, new leaflet updates and withdrawal of marketing authorizations of products).
8. Align and communicate registration plans to relevant local management.
9. Provide technical data and/or solutions required by local forecast and logistics.
10. Provide RA intelligence: Inform local management with current and emerging/changing national regulations which impact the drug development and /or filing & marketing processes.
11. Provide monthly reporting.
12. Identify major regulatory, clinical, technical or operational issues impacting on successful filing, approvals and variations/ maintenance and propose possible solutions.
13. Build an efficient regulatory networking with national regulators, local industry organizations and key opinion leaders.
Member of the PhRMA Levant working group.
1. Work on building and maintaining strong business relationship with the Health Authorities.
2. Work on improving distributor's RA performance related to BSP products: (time and quality of submission/approval)
3. Prepare registration file (tailored to the country requirements) and provide Table of Content to ensure proper controlling and tracking of the submitted documents.
4. Responsible for all pricing issues related to all BSP items.
5. Provide registration status and data required by local marketing and business
6. Align with local management concerning maintenance of the existing BSP portfolio (variations, renewals, pricing, new leaflet updates and withdrawal of marketing authorizations of BSP products, )
7. Align and communicate registration plans to relevant local management
8. Provide technical data and/or solutions required by local forecast and logistics.
9. Provide RA intelligence: Inform local management with current and emerging/changing national regulations which impact the drug development and /or filing & marketing processes.
10. Provide monthly reporting.
11. Identify major regulatory, clinical, technical or operational issues impacting on successful filing, approvals and variations/ maintenance and propose possible solutions.
12. Build an efficient regulatory networking with national regulators, local industry organizations and key opinion leaders.
