Regulatory Project Manager

Freyr Solutions
Stanford-le-Hope
4 days ago
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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.4years of experience in the Regulatory field and2years 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).

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