Regulatory Project Manager

JR United Kingdom; Luton; Remote; GBP 50,000 - 70,000; Full time

Job summary

A leading company in the Life Sciences industry is seeking a skilled Regulatory Project Manager to join their expanding team. This role involves managing key submissions, leading regulatory teams, and driving project timelines to ensure compliance with EU and US regulations. Applicants should possess a Bachelor's degree in a related field, significant experience in regulatory affairs, and excellent project management skills to thrive in a fast-paced environment.

Qualifications

• 5 years in Medicinal Products Regulatory Affairs with 2 years in Project Management.
• Experience with US / EU Major submissions.
• Intermediate proficiency with Microsoft Office products.

Responsibilities

• Manage Submission Working Groups (SWG) and Global Regulatory Teams (GRT).
• Lead non-SWG submission types independently.
• Support preparation of Regulatory Project Plans and timelines.

Skills

Project Management

Regulatory Affairs

Analytical Thinking

Business Collaboration

Education

Bachelor’s degree in Pharma / Medical or associated scientific discipline

Tools

Microsoft Project

Microsoft Office

Job description

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Regulatory Project Manager, luton, bedfordshire

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Client:

Freyr Solutions

Location:

luton, bedfordshire, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

31.05.2025

Expiry Date:

15.07.2025

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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. 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.