Overview

DRA Associate, UAE Jobs in Dubai at Sandoz

Title: DRA Associate, UAE

Company: Sandoz

Location: Dubai

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

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.

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.

Division

SANDOZ

Business Unit

Commercial OPS SIR SZ

Country

Utd.Arab Emir.

Work Location

Dubai

Company/Legal Entity

NOV MIDDLE EAST FZA UAE

Functional Area

Research & Development

Job Type

Full Time

Employment Type

Regular

Shift Work

No

Early Talent

Yes

About Sandoz