Job Description

• New Product Registrations - With supervision, evaluate, and prepare drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve a favourable outcome
• Maintenance of registered products - With supervision, maintain registration of currently approved products (initiation and preparation of variation/ and renewal applications as per the plan communicated from the DRA manager/Head).
• Close FU internally, with supervision, to reply to the enquiries received from the HA about the variations and renewal applications
• Initiate and prepare, with supervision, new or renewal registration of manufacturing site as per new and mature products registration plan in the assigned countries.
• Update local archives for manufacturing site new/renewal, variation update, renewal update
• Coordinate with DRA manager/head to ensure correct and speedy implementation / consignments as per the approved applications (variation/ renewal/ site transfer/ site registration/leaflet update).
• Maintain the internal DRA database accurate and updated: REGDB
• Comply with all the mandatory DRA training and Maintain updated records of DRA training/compliance training
• Relationships within and outside the company - Develop and maintain good working relationships with other Sandoz departments both locally and with Head Office and with health authority.
• With Supervision, Ensure full support to Global regulatory compliance initiatives including:

- REGDB/DRA database updates and verification.
- Registration and implementation of labelling changes.
- Preparation for Submission of Risk Management plans (RMP) and Periodic Safety Update Reports (PSURs).
- Ensure preparation for submission of new Safety (CDS) updates received from DRA Global.

• Monthly reporting of the activity to the DRA Manager/Head and Global DRA Functions
• Assist Medical Information and Quality Assurance with product detail requests wherever feasible. Assist Training Manager with Product Information training requirements wherever feasible.
• Review and Validation of the promotional material and regulatory support for the compliance committee.
• Product Information - responsible for cycle management of products Artworks Elements development and health authority approval. Responsible for maintenance of Artworks Elements in OneART for GLS cluster.
• With Supervision, Review PPMS and ensure Launch request are prepared and launched on time.
• Close follow up and monitoring of the regulatory activity with the local distributors ( Bi-weekly / or monthly meeting).
• Regulatory intelligence database update with close follow up of the latest circulars and guidelines issued from the Health Authorities, and immediate implementation within the company.
• Improve and encourage the compliance practices related to the DRA activity and Sandoz business.
• Regulatory support for the tender business

Minimum requirements

• Tertiary qualified - Pharmacy or Science (majoring in a life science or chemistry) with or without postgraduate qualifications
• Languages: Arabic and English written and spoken are mandatory.

Functional Area

Research & Development

Division

SANDOZ

Business Unit

Commercial OPS SIR SZ

Employment Type

Regular

Commitment to Diversity & Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Shift Work

No

Early Talent

Yes