About Freyr
Freyr is a fast-growing, innovative company specializing in providing end-to-end regulatory solutions and services for the Life Sciences industry. With a commitment to excellence and innovation, we assist pharmaceutical, medical device, and biotech companies in navigating the complexities of regulatory compliance.
Why Freyr?
At Freyr, we believe in fostering a collaborative and dynamic work environment that empowers our team to make a real impact. As we expand our footprint , we are on the lookout for passionate and skilled Regulatory professionals to join us in shaping the future of regulatory services.
Join Our Team:
If you're ready to embark on a journey of growth and innovation, connect with us to explore the exciting opportunities awaiting you at Freyr. Together, we can shape the future of regulatory solutions.
📢 To Apply:
Please apply to this job post or you can visit our Careers page for more openings
Visit our Careers page at (https://www.freyrsolutions.com/careers/current-positions) to explore current job openings and submit your application.
Don't miss this chance to be a part of Freyr's expansion and make your mark in the world of regulatory services. Let's redefine regulatory excellence together!
Title : Regulatory Project Manager
Location : Remote ( Base location should be in EU, preferably in 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 exp with IND/NDA/BLA
- PM experience - MS Projects
- SWG Meeting management( Driving cross functional Team meetings)
Key Responsibilities:
Submission Working Groups (SWG) management of –
- 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
Global Regulatory Teams (GRT) management of -
- Meetings support, as required.
- Regulatory Project Plan (RPP)
- GRT Goals
- Risks, Actions, Issues, Decisions (RAID)
Independently leading additional Non-SWG submission types
Requirements:
- Bachelor’s degree in Pharma / Medical or another associated scientific discipline OR equivalent
- Min. 4 years of experience in the Regulatory field and 2 years of demonstrated project management skill sets (required)
- Experience working with Microsoft Project or equivalent program (preferred).
- Experience in driving/supporting submissions for major markets - US, EU, etc. (e.g. IND, NDA, BLA, EU MAA, EU variations, etc.) would be preferred.
- Strong conceptual and analytical thinking skills.
- Ability to work under deadlines and fast-paced work environment.
- Excellent business collaboration/interpersonal skills.
- Intermediate proficiency in Microsoft Office products such as Word, Excel, and Outlook.
- Ability to multitask and prioritize competing assignments.
- Fluency in English (written, verbal, reading).
