Global Regulatory Lead

About Freyr

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 you can 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 a 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/ Croatia)

Experience : Min 8 years of direct experience with Medicinal Product Regulatory Affairs

Development Global Regulatory Liaison

Role Summary

• Serve as a global regulatory liaison (GRL) for select products.
• Leads a Global team of regulatory professionals covering the Product (indirectly and/or directly)
• Chairs Regulatory Project Team (RPT) meetings, with team, and affiliates, as applicable.
• Collaborates closely with either related product GRLs, or pediatric/adult GRL counterpart, as necessary.
• Accountable for the definition and execution of worldwide RA strategy for Product by:
• Providing leadership to advance the Product in-line with Client’s Corporate Objectives/ Project Team Goals
• Leverage RA experience of wider regional/in-country RA teams to provide technical and strategic guidance to Global Development Team (GDT) on innovative approaches, precedents, and possible risk mitigations of product.
• Build, maintain, and advance partnerships with key stakeholders across RA, and cross-functionally.

Key Activities

Strategic activities associated with this role may include, but is not limited to:

• Provide global regulatory leadership for key activities such as, global filings, Health Authority meetings, and internal governance product strategy
• RA Representation at key cross-functional meetings such as Global Development Team (GDT)
• Ensure global strategic alignment and execution across regions

Experience and Skillset

POSITION OVERVIEW

You will act as the Global Regulatory Liaison on more complex or multiple products, compounds, indications or projects in the assigned therapeutic area. You will typically be assigned multiple products or projects to lead, manage and oversee simultaneously. You will define the regulatory strategy, plans and objectives for assigned products or projects.

EXAMPLE RESPONSIBILITIES

• Makes significant contributions to the ongoing development and refinement of regulatory strategies, processes, standards, practices, efficiencies and capabilities.
• Represents Regulatory Affairs on cross-functional/cross-regional Regulatory Submission Teams. Provides strategic advice and guidance to Regulatory Affairs and cross-functional leaders and teams.
• Defines the regulatory strategy for multiple Client’s products or projects in the development phase.
• Proactively identifies regulatory or related risks/issues and develops mitigation and/or contingency plan.
• Oversees and guides the preparation, compilation, and timely filing of regulatory submissions, which require cross-functional interactions for investigational or marketed product(s).
• Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product license for assigned products and markets.
• Critically reviews documents for submission to regulatory authorities.
• Provides matrix management and leadership to project teams.
• Ensures own work complies with established practices, policies and processes, and any regulatory or other 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 regulatory, quality, compliance or related experience in the biopharma industry.
• Proven track record in effectively setting and directing the regulatory or related strategy to successful conclusion for one or more products or key markets.
• Experience and proven effectiveness working and negotiating with regulatory authorities.
• Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities.
• Demonstrated abilities to effectively delegate and manage others, as evidenced through either past people management or matrix management responsibilities.
• Experience working with one or more Client’s therapeutic areas and postmarketing phase strongly preferred.

Rest of World Education & Experience

BA/ BS or advanced degree in life sciences or related field with significant regulatory experience in the biopharma industry, regulatory agency, clinical research or other related healthcare environment. Experience leading a broad range of regulatory activities and setting the regulatory strategy for biopharmaceutical products.