Freyr is looking for a Regulatory Affairs Manager to play a vital role in developing and implementing regulatory strategies for clinical trial applications in the EU and UK. This position ensures adherence to clinical trial regulations and oversees submission activities, including lifecycle and compliance assessments in coordination with the Global Regulatory Lead (GRL).

About the Company

Freyr is a global Regulatory Solutions and Services organization dedicated to supporting Life Sciences companies in Regulatory Affairs, Clinical, Safety, and Compliance. We collaborate with leading pharmaceutical, biotechnology, and medical device firms, providing comprehensive regulatory operations support and strategic insights with precision and global expertise.

The Role

As a Regulatory Affairs Manager, you will be responsible for:

• Developing regulatory strategies and managing clinical trial application (CTA) submissions in the EU and UK, aligned with the GRL.
• Collaborating with the global regulatory team and other stakeholders to address regulatory issues and fulfill obligations.
• Leading initial and lifecycle CTA submissions, coordinating with Rapid Response Teams, and liaising with multidisciplinary teams and contract research organizations.
• Acting as a point of contact for health authorities regarding CTAs.
• Utilizing regulatory intelligence to navigate complex global requirements and challenges.
• Conducting quality checks on CTA submissions and ensuring compliance with submission portals.
• Supporting the preparation, submission, and lifecycle management of CTA submissions and related correspondence.
• Assisting in the development of regulatory operations work instructions and keeping up with regulatory updates.

Requirements

• Expert knowledge of EU Clinical Trial Regulation (CTR) and UK Medicines for Human Use (CTs) (Amendment) Regulations 2019.
• Proven experience in managing time-sensitive deliverables and leading multidisciplinary teams.
• Familiarity with Document Management Systems (preferably Documentum).
• Recent experience in submitting or leading CTA submissions in the EU or UK.
• Proficient in Microsoft Office (Word, Excel, Access, PowerPoint) and SharePoint.
• Strong ability to lead meetings, present information, and collaborate with international stakeholders in English.

What We Offer

• A chance to work within a collaborative, growth-oriented global regulatory team, supporting innovative clinical trials.
• Opportunities to lead complex CTA submissions and shape regulatory strategies in accordance with EMA, MHRA, and ICH guidelines.

Join Freyr and be part of impactful regulatory initiatives that enhance patient safety and promote global transparency.