Global Regulatory Lead

JR United Kingdom; Shrewsbury; Remote; GBP 70,000 - 100,000; Full time

Job summary

A leading company in the Life Sciences industry is seeking a Global Regulatory Lead / Associate Director to join their team. The role requires significant regulatory experience and a strong track record in strategic regulatory management. This position promotes a collaborative environment and offers opportunities to lead global regulatory initiatives across therapeutic areas while ensuring compliance and fostering partnerships. Join us on a journey of growth and innovation in shaping the future of regulatory solutions.

Qualifications

• Minimum 8 years of direct experience in Medicinal Product Regulatory Affairs.
• Proven experience in regulatory strategy and successful product approval.
• Significant regulatory, quality, or compliance experience in the biopharma industry.

Responsibilities

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

Skills

Regulatory Strategy

Leadership

Compliance

Negotiation

Project Management

Education

PharmD/PhD

MA/MS/MBA

BA/BS

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 looking 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, or 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).
• Chair Regulatory Project Team (RPT) meetings with team and affiliates, as applicable.
• Collaborate closely with related product GRLs or pediatric/adult GRL counterparts, as necessary.
• Define and execute worldwide RA strategy for the product by providing leadership to advance the product in line with client’s corporate objectives and project team goals.
• Leverage RA experience of regional/in-country RA teams to guide the global development team on innovative approaches, precedents, 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 such as GDT.
• Ensure global strategic alignment and execution across regions.

Experience and Skillset

Position Overview

Act as the global regulatory liaison for complex or multiple products, compounds, indications, or projects within the therapeutic area. Manage multiple products or projects simultaneously, defining regulatory strategies, plans, and objectives.

Example Responsibilities

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

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 regulatory strategy and successful product approval.
• Experience negotiating with regulatory authorities.
• Experience with clinical trials or drug development activities.
• Leadership or matrix management experience.
• Experience in therapeutic areas and post-marketing phases preferred.

Rest of World Education & Experience

Degree in life sciences or related field with significant regulatory experience in biopharma, regulatory agency, or clinical research. Experience leading regulatory activities and setting strategies for biopharmaceutical products.