Associate regulatory affairs specialist

Descripción del cargo

Responsibilities may include the following and other duties may be assigned

Responsible for the preparation, system entry, publication, quality control, and delivery of paper and electronic components of regulatory submissions and overall regulatory information (initial, amendments, product life cycle updates)
Submissions are produced with electronic publishing tools in compliance with document management standards. Regulatory information entries are managed using different regulatory systems and tools including data visualization dashboards and AI-assisted applications
Responsible for activities related to enterprise-wide regulatory management systems, including systems coordination, training others, developing and implementing plans, project support, and providing input to systems designs
Ensures continuous efficiency and effective process improvement measurements as part of KPI and value stream objectives, which also include but not limited to, project support, country-specific requirements compliance
Prepares, submits, tracks, indexes and archives paper and electronic submissions and regulatory information including license details, amendments, annual reports, general correspondence, adverse event reporting, promotional materials, regulatory payment, and other regulatory technical and administrative data – in different regulatory systems and tools
Required Knowledge and Experience: 

Bachelor's Degree Required in Allied Sciences (Medical/ biological science/ Engineering or equivalent field)

Fluent English

Minimum of 1 year job experience in similar and/or related role

Technology savvy – knowledge with power BI, Snowflake, RPA, or API is preferred

Database and Regulatory Systems Management

Good communication skills

Scientific knowledge, must be able to read and understand the technical document such as test report, raw data, drawing etc.

Computer skills (excellent knowledge of MS Office, Excel (V look), Word, affinity to computer systems (will use SAP, Calyx, RDR, etc.) and data management tools (PowerApps, Power BI  - PREFERED)