Global Regulatory Lead

JR United Kingdom; Bristol; Remote; GBP 80,000 - 120,000; Full time

Job summary

A fast-growing regulatory solutions company seeks a Global Regulatory Lead to drive regulatory strategies for products across regions. This remote position requires strong leadership and expertise in regulatory affairs to coordinate complex projects and ensure compliance, making a significant impact on the future of regulatory services.

Qualifications

• Minimum 8 years of direct experience in Medicinal Product Regulatory Affairs.
• Experience in developing regulatory strategies and managing submissions.

Responsibilities

• Serve as a global regulatory liaison for select products.
• Lead a global team of regulatory professionals.
• Define and execute worldwide regulatory strategy.

Skills

Leadership

Regulatory Affairs

Communication

Strategic Planning

Job description

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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 seeking 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.

How to Apply:

Please apply through this job post or visit our Careers page for more openings:

https://www.freyrsolutions.com/careers/current-positions

Don't miss this chance to be part of Freyr's expansion and make your mark in regulatory services. Let's redefine regulatory excellence together!

Position: Global Regulatory Lead / Associate Director - Regulatory Affairs

Location: Remote (Base location should be in UK/EU, preferably in Hungary, Poland, Romania, Czech Republic, or Croatia)

Experience: Minimum 8 years of direct experience in 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(s).
• Chair Regulatory Project Team (RPT) meetings with team and affiliates.
• Collaborate with related product GRLs or pediatric/adult GRL counterparts as necessary.
• Define and execute worldwide regulatory strategy for the product, providing leadership to align with client’s objectives and project goals.
• Leverage regional and in-country RA teams to provide strategic guidance and innovative approaches.
• Build and maintain partnerships with key stakeholders across RA and cross-functionally.

Key Activities

Strategic activities include:

• Provide global regulatory leadership for filings, health authority meetings, and internal governance.
• Represent Regulatory Affairs at key cross-functional meetings such as GDT.
• Ensure global strategic alignment and execution across regions.

Experience and Skillset

You will act as the Global Regulatory Liaison for complex or multiple products, managing and overseeing multiple projects simultaneously. You will define regulatory strategies, plans, and objectives.

Responsibilities include:

• Develop and refine regulatory strategies, processes, and standards.
• Represent Regulatory Affairs on cross-functional teams, providing strategic guidance.
• Define regulatory strategies for multiple products or projects.
• Identify regulatory risks and develop mitigation plans.
• Oversee regulatory submissions, labeling, and related documentation.
• Review documents for regulatory submissions.
• Provide leadership to project teams and ensure compliance with policies and regulations.