Global Regulatory Lead

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

Job summary

Freyr, a leading company in regulatory solutions for the Life Sciences industry, seeks a Global Regulatory Lead to oversee regulatory affairs for its products. The role involves strategic leadership in regulatory compliance, working closely with cross-functional teams, and managing global regulatory strategies. Ideal candidates will have significant experience in biopharma regulatory affairs with a track record of effective negotiation and compliance.

Qualifications

• Minimum 8 years of experience in Medicinal Product Regulatory Affairs.
• Experience in therapeutic areas and postmarketing activities preferred.

Responsibilities

• Serve as a global regulatory liaison for select products.
• Lead a global team of regulatory professionals.
• Oversee regulatory submissions and documentation updates.

Skills

Regulatory strategy

Project management

Stakeholder engagement

Risk management

Education

PharmD/PhD or MA/MS/MBA or BA/BS

Job description

Social network you want to login/join with:

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 a part of Freyr's expansion and make your mark in the world of 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/ 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 as necessary.
• Define and execute worldwide RA strategy for the product, providing leadership to align with client’s objectives and project goals.
• Leverage regional/in-country RA teams to guide global development strategies, risk mitigation, and innovative approaches.
• Build and maintain partnerships with key stakeholders across RA and cross-functional teams.

Key Activities

Strategic activities include:

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

Experience and Skillset

Position Overview

Act as the regulatory lead for complex products, managing multiple projects simultaneously, defining strategies and objectives.

Responsibilities

• Develop and refine regulatory strategies, standards, and practices.
• Participate in cross-functional teams and provide strategic guidance.
• Define regulatory strategies for multiple products or projects.
• Identify risks and develop mitigation plans.
• Oversee regulatory submissions, labeling, and documentation updates.
• Review documents for regulatory compliance.
• Provide leadership and matrix management to project teams.
• Ensure compliance with policies, practices, and regulatory requirements.

Requirements

• PharmD/PhD with 2+ years’ experience, or MA/MS/MBA with 8+ years, or BA/BS with 10+ years’ relevant experience.
• Significant regulatory, quality, or compliance experience in biopharma.
• Proven track record in regulatory strategy and negotiation with authorities.
• Experience with clinical trials and drug development activities.
• Leadership experience in managing teams or projects.
• Experience in therapeutic areas and postmarketing activities preferred.

Rest of World Education & Experience

Degree in life sciences or related field with substantial regulatory experience in biopharma, regulatory agencies, or clinical research. Proven ability to lead regulatory activities and set strategies for biopharmaceutical products.