Senior Regulatory Affairs Associate (Labelling)

Parexel • Bengaluru, Karnataka, India • 2w ago

Must have 4-6 years of experience in drug development especially in labeling, product package coordination, clinical supplies/packaging, supply chain regulatory affairs, or quality.
Good working knowledge of key labeling regulations/guidance and past experience in label development (CCDS, USPI, packaging)
Strong knowledge of US, EU, Switzerland, Canada and, Australia regulatory labeling lifecycle management
The ability to research and create comparator labeling documents.
Strong understanding and experience creating annual reports.
The ability to collaborate with Tech Ops for artwork implementation.
Proficiency in SPL (all aspects, types, and troubleshooting) and the ability to manage the review and approval of labeling in a document management system.
Managing label updates, compliance, and governance.
Electronic document management systems use and / or electronic submission experience.
Life Cycle Management, Post Approval Labeling submissions including PSUR submissions.
Co-ordinate artwork approval process of printed packaging components to meet packaging design and legislation requirements for each new product, new packs or changes to existing packaging.
Monitor, manage and control artwork changes.
To manage and maintain the Artwork Trackers & Systems.
To ensure artwork PDF’s are maintained and latest versions are readily available.
Liaise with relevant internal and external suppliers/departments to assist with implementation being achieved
Experience with consumer advertising and educational materials
Experience in handling Veeva, TVT, Docubridge etc.

Related Jobs

Sr Stat Programmer

RPL IQVIA RDS (India) Private Limited • Bengaluru, India • 5d ago

5d ago

Full-stack Developer (AI Solutions)

PSI CRO • Full-time • Bengaluru, Karnataka, India • 1w ago

1w ago

PySpark Python Consultant

IQVIA Analytics Services Private Limited (IN03) • Bengaluru, India • 2w ago

2w ago

CDM Programmer II (SAS)

Thermo Fisher Scientific • Full-time • Bangalore, Karnataka, India • 3w ago

3w ago

Senior Lead Clinical Data Science Programmer

ICON • Full-time • Bengaluru • 2m ago

2m ago

Statistical Programmer II

ICON • Full-time • Bangalore • 3m ago

3m ago

Senior Statistical Programmer I

ICON • Full-time • Bangalore • 3m ago

3m ago

Lead Clinical Data Science Programmer

ICON • Full-time • Bangalore • 5m ago

5m ago

Senior Clinical Data Science Programmer

ICON • Full-time • Bangalore • 5m ago

5m ago

Mid Level Statistical Programmer

ICON • Full-time • Bangalore • 5m ago

5m ago