Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Manage regulatory submissions and lead project teams in a dynamic environment.
- Company: Freyr is an innovative leader in regulatory solutions for the Life Sciences industry.
- Benefits: Enjoy remote work flexibility and be part of a collaborative team culture.
- Why this job: Join us to make a real impact in regulatory services and shape the future of compliance.
- Qualifications: 5 years in Medicinal Products Regulatory Affairs and 2 years in Project Management required.
- Other info: This role is remote, but candidates should be based in the EU, preferably UK or nearby countries.
The predicted salary is between 43200 - 72000 £ per year.
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!
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 experience 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).
Regulatory Project Manager employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Regulatory Project Manager
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and frameworks in the EU and US. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with major submissions like IND and NDA. Engaging in discussions or attending industry events can provide valuable insights and connections that may lead to job opportunities.
✨Tip Number 3
Showcase your project management skills by discussing specific projects you've led or contributed to in your previous roles. Highlighting your experience with SWG meetings and RAID logs can set you apart from other candidates.
✨Tip Number 4
Prepare for potential interview questions by practising how you would handle common challenges in regulatory project management. Think about examples where you've successfully navigated tight deadlines or complex regulatory requirements.
We think you need these skills to ace Regulatory Project Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your experience in Medicinal Products Regulatory Affairs and Project Management. Use specific examples that demonstrate your hands-on experience with IND/NDA/BLA submissions and your ability to manage cross-functional teams.
Craft a Compelling Cover Letter: Write a cover letter that reflects your passion for regulatory affairs and your understanding of the challenges faced by the Life Sciences industry. Mention how your skills align with Freyr's mission and values, and express your enthusiasm for contributing to their innovative solutions.
Highlight Relevant Skills: In your application, emphasise your project management skills, particularly your experience with Microsoft Project or similar tools. Showcase your ability to manage risks, actions, issues, and decisions effectively, as these are crucial for the role.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is essential in regulatory roles.
How to prepare for a job interview at Freyr Solutions
✨Showcase Your Regulatory Knowledge
Make sure to brush up on your knowledge of regulatory frameworks, especially those relevant to the US and EU. Be prepared to discuss your experience with major submissions like IND, NDA, and BLA, as this will demonstrate your expertise in the field.
✨Highlight Project Management Skills
Since the role requires project management experience, be ready to share specific examples of how you've successfully managed projects in the past. Discuss your familiarity with tools like Microsoft Project and how you've used them to drive project timelines and manage risks.
✨Prepare for Team Collaboration Questions
Freyr values collaboration, so expect questions about your experience working in cross-functional teams. Think of examples where you led or participated in Submission Working Groups (SWG) and how you facilitated effective communication among team members.
✨Demonstrate Problem-Solving Abilities
Be prepared to discuss how you've handled challenges in previous roles, particularly in a fast-paced environment. Highlight your analytical thinking skills and provide examples of how you've resolved issues or made decisions that positively impacted project outcomes.
