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- Tasks: Lead regulatory project management and coordinate submission working groups for life sciences.
- Company: Freyr is an innovative company providing regulatory solutions for the Life Sciences industry.
- Benefits: Enjoy remote work flexibility and be part of a dynamic, collaborative team.
- Why this job: Join us to make a real impact in regulatory services and shape the future of compliance.
- Qualifications: Bachelor’s degree in Pharma/Medical and 5 years in Regulatory Affairs with project management experience required.
- Other info: This role is remote but candidates should be based in the EU, preferably UK or Central Europe.
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. 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
- Project Management 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 the field.
✨Tip Number 2
Network with professionals in the regulatory affairs sector, especially those who have experience with major submissions like IND, NDA, or BLA. Engaging in discussions can provide insights and potentially lead to referrals.
✨Tip Number 3
Showcase your project management skills by discussing specific projects you've led, particularly those involving cross-functional teams. Highlighting your experience with tools like MS Project can set you apart from other candidates.
✨Tip Number 4
Prepare for potential interview questions by practising how you would manage risks and issues in a regulatory project. Being able to articulate your thought process will demonstrate your analytical skills and readiness for the role.
We think you need these skills to ace Regulatory Project Manager
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs and project management. Emphasise your hands-on experience with major submissions like IND, NDA, and BLA, as well as your proficiency in Microsoft Project.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the role and the company. Mention specific projects or experiences that align with Freyr's mission and values, and explain how you can contribute to their growth.
Highlight Key Skills: In your application, clearly outline your key skills such as analytical thinking, multitasking, and collaboration. Provide examples of how you've successfully managed cross-functional teams and driven project timelines.
Proofread Your Application: Before submitting, carefully proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial 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 driven cross-functional team meetings.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and how you handle challenges in a fast-paced environment. Think of scenarios where you've had to manage risks or make critical decisions, and be ready to explain your thought process.
✨Demonstrate Collaboration Skills
Freyr values a collaborative work environment, so be sure to highlight your interpersonal skills. Share examples of how you've worked effectively within teams, particularly in managing Submission Working Groups or Global Regulatory Teams.
