Regulatory Affairs Specialist - Labeling & Submissions

Planet Pharma; Alameda (CA); On-site; USD 41,000 - 50,000; Full time

Job summary

Planet Pharma in Alameda, CA seeks a Regulatory Affairs Specialist to support the Regulatory Affairs department and ensure compliant business processes. The individual may execute tasks and partner across business functions.

You will review labeling, advertising and promotional materials, determine risk, identify data needs, obtain data and ensure information supports claims. You’ll also participate in worldwide regulatory submissions, with strong growth and career development opportunities

Qualifications

• Bachelor’s degree or equivalent
• Minimum 2 years in a regulated industry
• Effective written and verbal communication
• Cross-functional collaboration
• Strong attention to detail and ability to manage projects

Responsibilities

• Review labeling, advertising and promotional materials for regulatory compliance
• Assist with promotional content development and review
• Support Ad & Promo SOP development and review
• Contribute to regulatory submissions for multiple markets
• Communicate requirements to cross-functional teams
• Support post-market regulatory activities

Skills

Regulatory affairs

Cross-functional collaboration

Project management

Attention to detail

Technical writing

Education

Bachelor’s degree

Regulatory affairs certification (RAC)

Tools

Word

Excel

PowerPoint

Visio

SharePoint

Job description

Planet Pharma in Alameda, CA seeks a Regulatory Affairs Specialist to support the Regulatory Affairs department and ensure compliant business processes. The individual may execute tasks and partner across business functions.

You will review labeling, advertising and promotional materials, determine risk, identify data needs, obtain data and ensure information supports claims. You’ll also participate in worldwide regulatory submissions, with strong growth and career development opportunities