CMC Strategist - Biosimilars

  •  

Raleigh, NC

Industry: Biotech/Pharma

  •  

Less than 5 years

Posted 382 days ago

  by    Nancy Christie

This job is no longer available.

Jr. CMC Strategist – Pharmaceutical

Our client is a leader in pharmaceutical solutions and is seeking to hire a Jr. CMC Strategist responsible for supporting the implementation of regulatory strategies in compliance with global regulations and guidances for pharmaceutical products. In this role, the Jr. CMC Strategist will help with the preparation and submission of regulatory CMC documents/reports.

Responsibilities:

  • Assist with development and review of regulatory strategies, CMC documentation and global submissions, reports, registration and necessary health authority responses
  • Biosimilar submissions: submissions include: IND, NDA, BLA/MMA, IMPD,
  • Determines submission strategy for proposed CMC changes
  • Ensure timely submission, resolving any CMC issues
  • Partner with product development, confirms CMC requirements throughout development process
  • Identify and assess CMC changes and global regulatory requirements, evaluating supporting documentation
  • Gains knowledge and develop understanding of regulatory guidances and regulations
  • Complies with Department and Company Standard Operating Procedures

Requirements:

  • Bachelor's Degreerequired preferably in Science, Chemistry or related field
  • Min. 3+ years’ experience in CMC Regulatory Affairs Strategy or related
  • Previous experience reviewing scientific information and data
  • Ability to work collaboratively, prioritize & multi-task
  • Strong communication, problem-solving & analytical skills
$80K - $100K