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Client:
Freyr Solutions
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Yes
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Job Views:
2
Posted:
22.08.2025
Expiry Date:
06.10.2025
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Job Description:
About Freyr
Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. We assist pharmaceutical, medical device, and biotech companies in navigating regulatory compliance.
Why Freyr?
We foster a collaborative and dynamic work environment that empowers our team. As we expand, we seek passionate Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
Explore exciting opportunities with Freyr. Together, we can redefine regulatory excellence.
To Apply:
Apply through this job post or visit our Careers page at https://www.freyrsolutions.com/careers/current-positions.
Be part of Freyr's expansion and make your mark in regulatory services!
Title: Regulatory Project Manager
Location: Remote (Base location in EU, preferably UK/Hungary/Poland/Romania/Czech/Croatia)
Experience: 5 years in Medicinal Products Regulatory Affairs with 2 years in Project Management.
Must have experience:
* US/EU Major submissions Experience
* Hands-on experience with IND/NDA/BLA
* Project Management experience - MS Projects
* SWG Meeting management (Driving cross-functional Team meetings)
Key Responsibilities:
Managing Submission Working Groups (SWG):
* SWG Kick-Off Meetings
* Recurrent SWG Meetings
* Detailed Regulatory Timelines
* Risks, Actions, Issues, Decisions (RAID) log
* Rapid Response Team (RRT)
* Lessons Learned log, as applicable
Managing Global Regulatory Teams (GRT):
* Meeting support as required
* Regulatory Project Plan (RPP)
* GRT Goals
* Risks, Actions, Issues, Decisions (RAID)
Leading additional Non-SWG submission types independently.
Requirements:
* Bachelor’s degree in Pharma/Medical or related scientific discipline or equivalent
* Minimum 4 years of Regulatory experience and 2 years in project management (required)
* Experience with Microsoft Project or similar (preferred)
* Experience supporting submissions for major markets (US, EU, etc.)
* Strong conceptual and analytical skills
* Ability to work under deadlines in a fast-paced environment
* Excellent interpersonal skills
* Proficiency in Microsoft Office (Word, Excel, Outlook)
* Ability to multitask and prioritize
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