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- Tasks: Lead global regulatory strategies and manage multiple projects in the life sciences sector.
- Company: Freyr is an innovative company providing regulatory solutions for the Life Sciences industry.
- Benefits: Enjoy remote work options and a collaborative, dynamic work environment.
- Why this job: Join us to make a real impact in regulatory services and shape the future of healthcare.
- Qualifications: 8+ years in Medicinal Product Regulatory Affairs; advanced degree preferred.
- Other info: This role is remote but candidates should be based in the UK or EU.
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 UK / EU - preferably in Hungary/ Poland / Romania/ Czech/ Croatia)
Experience: Min 8 years of direct experience with Medicinal Product Regulatory Affairs
Role Summary
- Serve as a global regulatory liaison (GRL) for select products.
- Lead a Global team of regulatory professionals covering the Product (indirectly and/or directly).
- Chairs Regulatory Project Team (RPT) meetings, with team, and affiliates, as applicable.
- Collaborates closely with either related product GRLs, or pediatric/adult GRL counterpart, as necessary.
- Accountable for the definition and execution of worldwide RA strategy for Product.
Key Activities
- Provide global regulatory leadership for key activities such as global filings, Health Authority meetings, and internal governance product strategy.
- RA Representation at key cross-functional meetings such as Global Development Team (GDT).
- Ensure global strategic alignment and execution across regions.
Experience and Skillset
POSITION OVERVIEW: You will act as the Global Regulatory Liaison on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects.
EXAMPLE RESPONSIBILITIES:
- Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
- Represents Regulatory Affairs on cross-functional/cross-regional Regulatory Submission Teams.
- Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
- Defines the regulatory strategy for multiple Client’s products or projects in the development phase.
- Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
- Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for investigational or marketed product(s).
- Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
- Critically reviews documents for submission to regulatory authorities.
- Provides matrix management and leadership to project teams.
- Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
REQUIREMENTS
Education & Experience:
- PharmD/PhD with 2+ years’ relevant experience.
- MA/MS/MBA with 8+ years’ relevant experience.
- BA/BS with 10+ years’ relevant experience.
- Significant regulatory, quality, compliance or related experience in the biopharma industry.
- Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets.
- Experience and proven effectiveness working and negotiating with regulatory authorities.
- Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
- Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
- Experience working with one or more Client’s therapeutic areas and postmarketing phase strongly preferred.
Rest of World Education & Experience:
- BA/BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment.
- Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.
Global Regulatory Lead employer: Freyr Solutions
Contact Detail:
Freyr Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Global Regulatory Lead
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience in global regulatory roles. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends in regulatory compliance.
✨Tip Number 2
Familiarise yourself with the specific regulatory frameworks and guidelines relevant to the biopharma industry. Understanding the nuances of different regions, especially the UK and EU, will give you an edge in discussions during interviews.
✨Tip Number 3
Prepare to discuss your previous experiences in leading regulatory projects and how you've successfully navigated challenges. Be ready to provide examples of how you've collaborated with cross-functional teams to achieve regulatory goals.
✨Tip Number 4
Research Freyr's recent projects and initiatives in regulatory affairs. Being knowledgeable about their work will not only show your interest but also allow you to tailor your conversation to align with their objectives during the interview process.
We think you need these skills to ace Global Regulatory Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, especially in the life sciences sector. Emphasise your leadership roles and any specific projects that align with the responsibilities of a Global Regulatory Lead.
Craft a Compelling Cover Letter: Your cover letter should reflect your passion for regulatory affairs and your understanding of the complexities involved. Mention specific experiences that demonstrate your ability to lead global teams and manage regulatory strategies effectively.
Highlight Key Skills: In your application, focus on key skills such as strategic thinking, risk management, and cross-functional collaboration. Use examples from your past work to illustrate how you've successfully navigated regulatory challenges.
Showcase Your Education: Clearly state your educational background, particularly if you have a PharmD, PhD, or other relevant advanced degrees. Highlight any additional certifications or training that are pertinent to regulatory affairs in the biopharma industry.
How to prepare for a job interview at Freyr Solutions
✨Understand the Regulatory Landscape
Familiarise yourself with the current regulatory environment in the life sciences industry. Be prepared to discuss recent changes in regulations and how they might impact Freyr's operations.
✨Showcase Your Leadership Skills
As a Global Regulatory Lead, you'll be expected to lead teams and projects. Prepare examples of how you've successfully managed teams or projects in the past, highlighting your ability to guide and influence others.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills in real-world regulatory scenarios. Think about challenges you've faced in previous roles and how you navigated them, particularly in relation to regulatory submissions and compliance.
✨Demonstrate Cross-Functional Collaboration
Freyr values collaboration across various teams. Be ready to discuss your experience working with cross-functional teams and how you’ve effectively communicated and negotiated with different stakeholders.