Global Regulatory Lead

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

Job summary

Freyr is seeking a Global Regulatory Lead/Associate Director to oversee regulatory affairs and strategies for medicinal products. Candidates need at least 8 years of experience in regulatory roles and a strong background in the biopharma industry. The position offers remote work flexibility, aiming to expand Freyr's footprint in life sciences regulation.

Qualifications

• 8+ years' experience in Medicinal Product Regulatory Affairs.
• Significant regulatory, quality, compliance experience in biopharma.
• Management experience in regulatory affairs, with proven track record.

Responsibilities

• Lead a global team of regulatory professionals.
• Define and execute worldwide regulatory strategies.
• Oversee and guide regulatory submissions.

Skills

Regulatory Strategy

Negotiation with Authorities

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 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 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 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 the 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 provide technical and strategic guidance to the Global Development Team (GDT) on innovative approaches, precedents, and risk mitigation.
• Build, maintain, and advance partnerships with key stakeholders across RA and cross-functionally.

Key Activities

Strategic activities may 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

You will act as the Global Regulatory Liaison for complex or multiple products, compounds, indications, or projects in the assigned therapeutic area. You will manage multiple products or projects simultaneously, defining regulatory strategies, plans, and objectives.

Example Responsibilities

• Contribute to the development and refinement of regulatory strategies, processes, standards, and efficiencies.
• Represent Regulatory Affairs on cross-functional teams, providing strategic advice and guidance.
• Define regulatory strategies for multiple products or projects in development.
• Identify regulatory risks/issues proactively and develop mitigation plans.
• Oversee and guide regulatory submissions, labeling, packaging, and 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 experience in the biopharma industry.
• Proven track record in regulatory strategy and negotiation with authorities.
• Experience in clinical trials or drug development activities.
• Management experience, either people or matrix management.
• Experience with 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 agencies, or clinical research. Experience leading regulatory activities and setting strategies for biopharmaceutical products.