Senior Regulatory Affairs Consultant in Tampa, FL at Eliassen Group

Date Posted: 8/4/2022

Job Snapshot

Job Description

**100% Remote or onsite in Tampa at candidate's preference**

Our Fortune 500 pharma client needs a Senior Regulatory Affairs Consultant to support an influx of work around submissions and change controls for their Cell & Gene Therapy products.

Contract Length: 12 months, with the possibility of extension/conversion

Requirements of the Senior Regulatory Affairs Consultant:
  • Bachelor's degree and 5+ years of regulatory affairs systems and process experience
  • Strong ability to make risk-based decisions
  • Experience authoring Module 3 and defining regulatory strategy
  • CMC experience: API, drug product, manufacturing and validation highly preferred
  • eCDT and CTD documentation experience
  • Experience with CBE30 and other post approval changes 
  • Biologics/BLA or Cell & Gene therapy experience required
  • Experience leading and communicating with global teams
Job ID: 369497

About EG Life Sciences:

Founded in 2010, EG Life Sciences is a national professional services firm that delivers strategic consulting and innovative solutions for the pharmaceutical, biologic, medical device, and diagnostic industries. We provide tailored services to clients seeking to manage challenges, improve time-to-market, and fine-tune clinical development and operations. Our team is comprised of dedicated professionals and FDA-regulated industry specialists, each averaging over 20 years of related experience. This combination of services and team members enables us to quickly deliver value-driven life sciences consulting, project management and leadership, and customized project-based solutions.

Eliassen Group is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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