Regional Regulatory Lead

For Candidates currently located in UK

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 to Warsaw, Poland, 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's new chapter in Warsaw, Poland. 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 : Regional Regulatory Lead / Associate Director - Regulatory Affairs

Location : UK

Development Products Regional Regulatory Liaison (RRL)

Role Summary

• Serve as a regional regulatory lead (RRL) in the EU and be the point of contact for the local health authority (EMA) for select products.
• Accountable for the definition and execution of regional RA strategy for assigned products) which includes, but is not limited to:
• Provide knowledge and input to global regulatory lead (GRL) to advance the product in-line with Corporate Objectives/Development Products Project Team (EPT) Goals
• Ensure fulfilment of regional regulatory commitments, in addition to supporting the regulatory submission activities.
• Leverage RA experience of wider regional/in-country affiliate RA teams to provide technical and strategic guidance to Global Regulatory Lead (GRL) on innovative approaches, precedents, and possible risk mitigations of product.
• Represent the regulatory department and actively participate at cross functional teams.
• To act as the subject matter expert (SME) and provide valid regulatory guidance to support ongoing regulatory activities (e.g. EU)
• Build and maintain strong relationships with cross-functional teams.
• Build, maintain, and advance partnerships with key stakeholders across RA.
• Act as a delegate for GRL, as appropriate Key activities

Experience & skillset

Position Overview for Development products

The Regional Regulatory Lead for Clinical Trial Applications (CTA) will play a critical role in overseeing the drug development, regulatory strategy and submission processes for clinical trial plan within the EU region. This individual will collaborate with cross-functional teams to ensure compliance with local regulations and facilitate timely approval of CTAs/INDs.

Example Responsibilities

• Regulatory Strategy Development: Lead the development of regulatory strategies for CTAs in alignment with EU regulatory requirements.
• Tracking of Development: Track the development of the drug and collaborate with applicable stake holders to ensure meeting the timelines
• Submission Management: Oversee the preparation, submission, follow-up with all stake holders and follow-up of CTAs to EU regulatory authorities, ensuring all documentation meets required standards.
• Cross-Functional Collaboration: Collaborate with clinical, medical, Quality and operational teams to ensure regulatory requirements are integrated into drug development/clinical development plans.
• Stakeholder Engagement: Serve as the primary point of contact for regulatory agencies and internal stakeholders, addressing inquiries, providing guidance and providing updates on submission status.
• Regulatory Intelligence: Stay current on regional regulatory changes, guidelines, and best practices related to clinical trials/drug development, and communicate these insights to relevant teams.
• Risk Assessment: Identify and mitigate potential regulatory risks associated with drug development/clinical trial design and execution.
• HA Interactions: Guidance in the preparation and submission of Pre-submission meeting packages and participate in HA meetings. Ensure implementation of HA suggestions. MoM preparation and necessary guidance to stake holders for drug/clinical development
• Training and Support: Ensure necessary training and support provided to internal teams on regulatory requirements and submission processes.
• Documentation and Reporting: Maintain accurate records of submissions and regulatory correspondence, ensuring compliance with internal policies and procedures

Requirements

Education & Experience

• PharmD/PhD with some relevant experience.
• MA/MS/MBA with 6+ years' relevant experience.
• BA/BS with 8+ years' relevant experience.
• Significant regulatory, quality, compliance or related experience supporting medicinal products.
• Significant regulatory experience in the biopharma industry is strongly preferred.
• Experience setting the regulatory strategy and leading regulatory submissions and other activities for a medicinal product is strongly preferred.
• Experience successfully leading departmental and cross-functional teams without authority.
• Experience authoring and implementing processes.
• Experience working with one or more client therapeutic areas and in the post marketing stage of drug development is strongly preferred.