Reg Affairs Lead
- Employer
- IQVIA
- Location
- Warsaw
- Start date
- 6 Feb 2021
- Closing date
- 7 Mar 2021
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
To perform this job successfully, an individual must demonstrate project management skills and strong expertise.
Essential functions:
- Prepares and reviews regulatory submissions on behalf of clinical research studies and secures marketing authorizations.
- Technical writing to complete regulatory and/or technical documents to ensure complete and high-quality regulatory deliverables.
- Communicates regulatory issues and opportunities to customers.
- Provides strategic regulatory guidance to project teams.
Qualifications:
- Degree in Lifescience
- 2 or more years in a Project Management role leading similar sized efforts.
- 4 or more years working in a Regulatory role assisting in the developing regulatory submission documents.
- Experience in regulatory requirements for an asset transfer .
- Direct experience with program management of regulatory affairs projects.
- Effective communication skills.
- Strong leadership skills.
- Good decision maker.
LI-MS8
At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.
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