Senior Regulatory Affairs Specialist

IQVIA

Bachelor's or master's degree in lifescience
3-4 years relevant regulatory experience
Expertise in chemistry manufacturing and controls
The role involves acting as a Regulatory Team Leader on complex projects including technical writing and lifecycle maintenance

Job Summary

  • The role involves acting as a Regulatory Team Leader on complex projects including technical writing and lifecycle maintenance.
  • Candidates must possess specific expertise in areas such as Marketing Authorization Transfers, Labeling, and Publishing.
  • The position requires establishing relationships with customers and potentially presenting complex regulatory processes at large full service bid defense meetings.

Matching Summary

The role involves acting as a Regulatory Team Leader on complex projects including technical writing and lifecycle maintenance.

Skills & Requirements

Must-have

  • Bachelor's or Master's degree in Lifescience
  • 3-4 years relevant regulatory experience
  • Expertise in Chemistry Manufacturing and Controls
  • Strong technical writing skills for documentation
  • Ability to manage project budgets and deliverables

Nice-to-have

  • Experience presenting at bid defense meetings
  • Ability to train junior colleagues effectively
  • Self-motivation and enthusiasm for work
  • Adaptability to rapidly changing environments
  • Strong interpersonal communication skills

Key Requirements

  • Bachelor's Degree in Lifescience or related discipline
  • Master's Degree in Lifescience or related discipline
  • At least 3-4 years of relevant experience
  • Advanced knowledge within a specific regulatory discipline
  • Applicable certifications and licenses as required by country

Work Rights

Not specified

Tailored Resume

Cover Letter