Global Regulatory Lead

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

Job summary

Une entreprise spécialisée dans les solutions réglementaires cherche à recruter un Global Regulatory Lead. Le rôle implique la gestion des affaires réglementaires pour des projets complexes, en travaillant avec des équipes internationales. Le candidat idéal aura une expérience significative en stratégies réglementaires et en gestion d'équipe, et sera responsable de la liaison entre les parties prenantes tout en s'assurant de la conformité aux réglementations applicables.

Qualifications

• Minimum 8 ans d'expérience en affaires réglementaires pour produits médicinaux.
• Diplôme en sciences pharmaceutiques ou domaine connexe requis.
• Expérience en gestion de projets et d'équipes.

Responsibilities

• Servir de liaison réglementaire mondiale pour des produits sélectionnés.
• Définir et exécuter la stratégie réglementaire mondiale pour le produit.
• Diriger des équipes de projet réglementaire.

Skills

Regulatory Strategy

Leadership

Project Management

Cross-functional Collaboration

Risk Mitigation

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.

How 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!

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 (directly and/or indirectly).
• 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 objectives.
• Leverage regional/in-country RA team experience to guide global development strategies, risk mitigation, and innovative approaches.
• 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

You will act as the Global Regulatory Liaison for complex products or projects, managing multiple simultaneously. Responsibilities include defining regulatory strategies, managing submissions, and leading cross-functional teams.

• Contribute to the development of regulatory processes, standards, and efficiencies.
• Represent Regulatory Affairs on cross-regional teams, providing strategic guidance.
• Define regulatory strategies for multiple products in development.
• Identify and mitigate regulatory risks proactively.
• Oversee regulatory submissions, labeling, and documentation updates.
• Provide leadership and management to project teams.
• Ensure compliance with all relevant 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.
• Extensive regulatory, quality, or compliance experience in biopharma.
• Proven track record in regulatory strategy and negotiations with authorities.
• Experience in clinical trials or drug development projects.
• Leadership experience in managing teams or matrix environments.
• Experience in therapeutic areas and post-marketing activities preferred.

Additional Qualifications

Degree in life sciences or related field with significant regulatory experience. Proven ability to lead regulatory activities and set strategies for biopharmaceutical products.