Senior Regulatory Affairs Associate (Labelling)

Parexel

4 - 6 years

0 Lacs

bengaluru karnataka india

Posted:1 month ago| Platform:

Apply

Skills Required

development labeling coordination packaging regulations research spl troubleshooting management compliance design pdf

Work Mode

On-site

Job Type

Full Time

Job Description

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.

More Jobs at Parexel

Partnership Project Data Coordinator

Delhi, Delhi

Experience: Not specified

Salary: Not disclosed

Principal Statistical Programmer- FSP

Delhi, Delhi

Experience: Not specified

Salary: Not disclosed

Quality Manager

Serilingampalli, Telangana, India

5 - 8 yrs

Salary: Not disclosed

Medical Writer I

Delhi, Delhi

Experience: Not specified

Salary: Not disclosed

System Validation Services - Specialist II

Hyderabad

5 - 5 yrs

INR 9 - 11 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.