Global Regulatory Lead

JR United Kingdom; United Kingdom; Remote; GBP 70,000 - 110,000; Full time

Job summary

Freyr, a fast-growing innovative company in regulatory solutions for the Life Sciences industry, is seeking a Global Regulatory Lead. This remote position, ideally based in the UK or EU, requires a minimum of 8 years in regulatory affairs and offers an exciting opportunity to shape the future of regulatory services. Join a dynamic team to lead regulatory strategies and ensure compliance while making a real impact in the biopharma sector.

Qualifications

• 8+ years of experience in Medicinal Product Regulatory Affairs.
• Significant regulatory, quality, or compliance experience in biopharma.
• Proven track record in regulatory strategy and negotiation.

Responsibilities

• Lead global regulatory teams and strategy for multiple products.
• Oversee regulatory submissions and ensure compliance.
• Identify regulatory risks and develop mitigation plans.

Skills

Regulatory Affairs

Leadership

Strategic Planning

Cross-functional Collaboration

Education

PharmD/PhD with 2+ years relevant experience

MA/MS/MBA with 8+ years relevant experience

BA/BS with 10+ years relevant experience

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!

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 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 teams to provide strategic guidance to 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 strategies.
• Represent Regulatory Affairs at key cross-functional meetings such as the Global Development Team.
• Ensure global strategic alignment and execution across regions.

Experience and Skillset

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

Responsibilities include:

• Contribute to the development and refinement of regulatory strategies, processes, and practices.
• Represent Regulatory Affairs on cross-functional teams, providing strategic advice.
• Define regulatory strategies for multiple products or projects.
• Identify regulatory risks and develop mitigation plans.
• Oversee regulatory submissions and ensure compliance with licensing requirements.
• Guide labeling, packaging, and information 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, or compliance experience in biopharma.
• Proven track record in regulatory strategy and negotiation with authorities.
• Experience in cross-functional projects related to clinical trials or drug development.
• Leadership and management experience, either directly or matrixed.
• Experience in 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 biopharmaceutical products.