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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 exciting opportunities at Freyr. Together, we can redefine regulatory excellence.

? 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. Join us in shaping the future!

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

Minimum 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, providing leadership to align with client’s corporate objectives and project goals.
• Leverage regional/in-country RA teams to guide global development strategies, mitigate risks, and ensure compliance.
• Build and maintain partnerships with key stakeholders across RA and cross-functionally.

Key Activities

Strategic activities include:

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

Experience and Skillset

Position Overview

Act as the Global Regulatory Liaison for complex or multiple products/projects, defining regulatory strategies and managing multiple assignments simultaneously.

Responsibilities

• Contribute to the development 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 risks and develop mitigation plans.
• Oversee regulatory submissions, labeling, and documentation updates.
• Review documents for regulatory submissions.
• Provide leadership and matrix management to project teams.
• Ensure compliance with policies and regulatory 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.
• Extensive regulatory, quality, or compliance experience in biopharma.
• Proven track record in regulatory strategy and successful product approvals.
• Experience negotiating with regulatory authorities.
• Participation in cross-functional projects related to clinical trials or drug development.
• Leadership experience, including managing teams or matrix management.
• Experience with therapeutic areas and post-marketing activities preferred.

Rest of World Education & Experience

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