Global Regulatory Lead

JR United Kingdom; Wolverhampton; Remote; GBP 70,000 - 120,000; Full time

Job summary

A fast-growing innovative company, Freyr, is seeking a Global Regulatory Lead / Associate Director to join their team. The role involves leading regulatory strategies for medicinal products, managing a global team, and ensuring compliance with regulatory requirements. Ideal candidates will have significant experience in regulatory affairs, particularly in the biopharma sector. This is a remote position based in the UK/EU.

Qualifications

• Minimum 8 years of direct experience in Medicinal Product Regulatory Affairs.
• Significant regulatory experience within the biopharma industry.
• Experience in clinical trials or drug development.

Responsibilities

• Lead global regulatory strategies for complex products.
• Oversee regulatory submissions and ensure compliance.
• Manage cross-functional teams and provide strategic guidance.

Skills

Regulatory strategy

Negotiation with regulatory authorities

Leadership

Risk management

Project management

Education

PharmD/PhD

MA/MS/MBA

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 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 at Freyr. Together, we can redefine regulatory excellence.

How to Apply:

Please apply through this job post or visit our Careers page for more openings: Freyr Careers Page

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 of regulatory solutions!

Position: Global Regulatory Lead / Associate Director - Regulatory Affairs

Location: Remote (Base location should be in UK/EU, preferably Hungary, Poland, Romania, Czech Republic, or Croatia)

Experience: Minimum 8 years of direct experience in 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 either directly or indirectly.
• Chair Regulatory Project Team (RPT) meetings with team members and affiliates as applicable.
• Collaborate closely with related product GRLs or pediatric/adult GRL counterparts as necessary.
• Define and execute worldwide regulatory strategies for the product, providing leadership aligned with client’s corporate objectives and project goals.
• Leverage regional and in-country RA team experience to guide global development strategies, mitigate risks, and explore innovative approaches.
• Build and maintain partnerships with key stakeholders across RA and cross-functionally.

Key Activities

Strategic activities include, but are not limited to:

• Providing global regulatory leadership for filings, health authority meetings, and internal governance.
• Representing Regulatory Affairs in key cross-functional meetings such as the Global Development Team (GDT).
• Ensuring strategic alignment and execution across regions.

Experience and Skillset

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

Responsibilities include:

• Contributing to the development and refinement of regulatory strategies, processes, and standards.
• Representing Regulatory Affairs in cross-functional teams and providing strategic guidance.
• Defining regulatory strategies for multiple products or projects in development.
• Identifying risks and developing mitigation plans proactively.
• Overseeing regulatory submissions, labeling, packaging, and information updates.
• Reviewing submission documents for regulatory authorities.
• Providing leadership and matrix management to project teams.
• Ensuring compliance with practices, 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.
• Significant experience in regulatory, quality, or compliance roles within the biopharma industry.
• Proven track record in regulatory strategy and successful product approvals.
• Experience negotiating with regulatory authorities.
• Experience in clinical trials or drug development projects.
• Leadership experience, including managing or matrix-managing teams.
• Experience in therapeutic areas and post-marketing activities is preferred.

Rest of World Education & Experience:

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