Strides Pharma Hiring Regulatory Affairs Professional in Bangalore

Join Strides Pharma as a Regulatory Affairs Professional in Bangalore

Are you an experienced Regulatory Affairs professional looking for new opportunities in Bangalore? Strides Pharma is seeking talented individuals to join their team in handling Regulatory Affairs for the Europe/UK Market. This article provides insights into the qualifications required, job vacancies, and the location details for these exciting roles.

Job Description:

Position: Regulatory Affairs Professionals (Europe/UK Market)

Location: Bangalore

Experience: 4-7 years preferred

Responsibilities:

• Prepare and deliver accurate, consistent, timely labelling documents for submission in Europe and UK region
• Subject Matter Expert EU Regulatory, submission Labeling requirements, labeling change control, and potential labeling issues.
• Assist in the review and response of HA queries relating to labeling.
• Coordinate translation, review, submission to Member States (MS), discussion of MS’s proposed changes and final submission of language PIs to HA’s.
• Perform quality control of language PIs ensuring compliance with EN PI and language-specific Quality Review of Documents (QRD) templates/guidelines and terminology consistency within language PI/across other approved PIs.
• Responsible for review and compilation of change control workflows for updates to labelling text and artwork for multiple products marketed in Europe and UK.
• Proactively identifies risks and issues and develops solutions to challenging areas related to assigned projects in the interest of keeping projects streamlined and moving forward.
• Approve and maintain artwork for EU packaging components when artwork is approved to be printed “at risk”
• Maintain up-to-date knowledge of EU regulatory labeling requirements, assessing and communicating impact on business and products.

How to Apply

If you meet the qualifications and are interested in joining Strides Pharma in Bangalore, please share your profile with Navya@arcolab.com.