Global Regulatory Lead

JR United Kingdom; Stockport; Remote; GBP 60,000 - 90,000; Full time

Job summary

A leading company in regulatory solutions is seeking a Global Regulatory Lead to oversee multiple projects in the life sciences sector. The ideal candidate will have extensive experience in regulatory affairs and a proven ability to manage teams and define strategies. This role is pivotal in guiding product development and ensuring compliance across global markets.

Qualifications

• 8+ years of relevant experience in regulatory affairs.
• Proven track record with regulatory authorities.
• Leadership experience managing teams.

Responsibilities

• Lead global regulatory teams and direct strategy.
• Oversee regulatory submissions and compliance.
• Provide strategic advice on regulatory risks.

Skills

Regulatory Strategy

Leadership

Project Management

Regulatory Compliance

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 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 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!

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 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 align with client’s corporate objectives and project goals.
• Leverage RA experience of regional/in-country teams to provide strategic guidance to the Global Development Team (GDT).
• Build and maintain 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 on complex or multiple products, managing and overseeing multiple projects simultaneously. You will define regulatory strategies and plans for these products.

Responsibilities

• Contribute to the development and refinement of regulatory strategies, processes, and standards.
• Represent Regulatory Affairs on cross-functional teams, providing strategic advice.
• Define regulatory strategy for multiple products or projects in development.
• Identify regulatory risks and develop mitigation plans.
• Oversee regulatory submissions, labeling, and product 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 experience in regulatory, quality, or compliance roles within the biopharma industry.
• Proven track record in regulatory strategy and negotiations with authorities.
• Experience in clinical trials or drug development activities.
• Leadership experience, including managing or matrix managing teams.
• Experience in therapeutic areas and postmarketing phases is preferred.

Rest of World Education & Experience

Degree in life sciences or related field with significant regulatory experience in biopharma, regulatory agencies, or healthcare. Experience leading regulatory activities and setting strategies for biopharmaceutical products.