Global Regulatory Lead

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

Job summary

A leading company in regulatory solutions is seeking a Global Regulatory Lead / Associate Director to lead regulatory efforts within the Life Sciences industry. This role involves strategic oversight and management of regulatory affairs across multiple products and therapeutic areas, with a focus on compliance and innovation. Candidates should possess a minimum of 8 years of experience in Medicinal Product Regulatory Affairs, with responsibilities including team leadership, cross-functional collaboration, and risk mitigation. This is a remote position based in the UK or EU.

Qualifications

• Minimum 8 years of direct experience with Medicinal Product Regulatory Affairs.
• Experience leading regulatory teams and defining regulatory strategies.

Responsibilities

• Serve as a global regulatory liaison for select products.
• Lead a global team of regulatory professionals and ensure strategic alignment.
• Oversee preparation and submission of regulatory documents.

Skills

Regulatory Affairs

Leadership

Strategic Thinking

Cross-Functional Teamwork

Risk Mitigation

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 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 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 part of Freyr's expansion and make your mark in regulatory services. Let's redefine regulatory excellence together!

Title

Global Regulatory Lead / Associate Director - Regulatory Affairs

Location

Remote (Base location should be in UK / EU - preferably in Hungary, Poland, Romania, Czech Republic, 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, directly and/or indirectly.
• Chair Regulatory Project Team (RPT) meetings with team and affiliates, as applicable.
• Collaborate closely with related product GRLs or pediatric/adult GRL counterparts.
• Define and execute worldwide RA strategy for the product, providing leadership to align with corporate objectives and project goals.
• Leverage regional RA teams to provide strategic guidance on innovative approaches and risk mitigation.
• Build and maintain partnerships with key stakeholders across RA and cross-functionally.

Key Activities

Strategic activities may include:

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

Experience and Skillset

Position Overview

Act as the global regulatory liaison for complex products or projects in the assigned therapeutic area, managing multiple initiatives simultaneously. Define regulatory strategies and plans for these products or projects.

Responsibilities

• Contribute to the development of regulatory strategies, processes, and standards.
• Represent Regulatory Affairs in cross-functional teams and provide strategic guidance.
• Define regulatory strategies for multiple products in development.
• Identify and mitigate regulatory risks.
• Oversee preparation and submission of regulatory documents.
• Guide labeling, packaging, and information updates.
• Review documents for regulatory submissions.
• Provide leadership to project teams.
• Ensure compliance with policies and regulations.