Regulatory Project Manager

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 ManagerLocation : 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:

1. Bachelor’s degree in Pharma / Medical or another associated scientific discipline OR equivalent
2. Min. 4 years of experience in the Regulatory field and 2 years of demonstrated project management skill sets (required)
3. Experience working with Microsoft Project or equivalent program (preferred).
4. Experience in driving/supporting submissions for major markets - US, EU, etc. (e.g. IND, NDA, BLA, EU MAA, EU variations, etc.) would be preferred.
5. Strong conceptual and analytical thinking skills.
6. Ability to work under deadlines and fast-paced work environment.
7. Excellent business collaboration/interpersonal skills.
8. Intermediate proficiency in Microsoft Office products such as Word, Excel, and Outlook.
9. Ability to multitask and prioritize competing assignments.
10. Fluency in English (written, verbal, reading).