Regulatory Affairs Manager EU/UK CTA/CTR (Waterloo)

About Freyr

Freyr is a leading global Regulatory Solutions and Services company, supporting large, mid, and small-sized global Life Sciences companies. With a mission to accelerate compliance and enable businesses to bring their products to market faster, Freyr operates in a dynamic, creative, and collaborative environment. Our team of experts works on cutting-edge projects that drive meaningful impact across pharmaceuticals, biotechnology, cosmetics, food, and medical devices industries.

At Freyr, we believe in fostering talent and creating an inclusive work culture where employees are empowered to succeed. Join a company that values innovation, integrity, and the power of collaboration.

Job Title: Clinical Trial Submissions (CTS) Strategy Support

Location: Remote

Employment Type: Permanent/Full-Time

Role Overview:

The Clinical Trial Submissions (CTS) Strategy Support provides operational and strategic support to CTS Strategy Leads in the planning and execution of Clinical Trial Authorization (CTA) submissions. The role involves document tracking, cross-functional coordination, and ensuring timely delivery of submission components in compliance with EU/UK Clinical Trial Regulations and ICH-GCP guidelines.

Key Responsibilities

Primary Responsibilities

• Support CTS Strategy Leads in preparation, quality control (QC), and compilation of CTA submission documents.
• Track document provision activities, including proactive follow-up with stakeholders and CROs to ensure timely delivery.
• Assist in maintaining detailed trackers for CTA submission deliverables and timelines.
• Support preparation of meeting minutes, action items, and follow-ups for submission-related meetings.
• Coordinate with cross-functional teams to align on submission requirements and timelines.

Secondary Responsibilities

• Support operational activities related to CTA submissions across the full clinical trial lifecycle (EU/UK regions).
• Coordinate with vendors for translation activities, where required.
• Manage multiple deliverables and competing priorities in a structured manner.
• Contribute to process improvement initiatives, as assigned.

Interactions

• Collaborate with CTS Strategy Leads, Regulatory Affairs, Clinical Operations, and CRO partners.
• Engage with global stakeholders across different time zones.
• Coordinate with external vendors for document and translation support.

Qualifications & Experience

Education

• Bachelor’s degree in Life Sciences or equivalent professional experience.

Technical Skills

• Knowledge of EU/UK Clinical Trial Regulations and ICH-GCP guidelines.
• Hands-on experience with Electronic Document Management Systems (EDMS).
• Proficiency in Microsoft Office tools (Word, Excel, PowerPoint, SharePoint).
• Understanding of submission document preparation, QC, and compilation processes.

Experience

• 3–5 years of experience in the pharmaceutical/biotech industry, preferably in Regulatory Affairs or Regulatory Operations.
• Experience supporting CTA submission activities and working with cross-functional teams.
• Exposure to CRO coordination and submission document tracking.

Soft Skills

• Strong attention to detail and organizational skills.
• Ability to manage multiple priorities and meet deadlines independently.
• Effective verbal and written communication skills in English.
• Collaborative mindset with the ability to work across global teams.
• Self-motivated, proactive, and adaptable with a learning-oriented approach.

Additional Expectations

• Act as a support function to Strategy Leads with a strong focus on execution and tracking.
• Proactively manage deliverables and anticipate operational needs.
• Ensure timely communication and alignment across stakeholders.
• Maintain high-quality standards in documentation and tracking activities.

What We Offer:

Competitive salary and benefits package.

Flexible work environment (remote or hybrid options available).

Opportunity to work with a global team and contribute to impactful projects.

Continuous professional growth through training and development programs.

Inclusive, collaborative, and innovative work culture.

Why Join Freyr:

Be part of a global, fast-growing organization that operates in over 150 countries.

Opportunity to work on impactful projects in a dynamic and innovative environment.

Competitive salary and benefits package, including performance-based incentives.

Flexible work options to support work-life balance.

Continuous learning and career development opportunities.

Collaborative and inclusive work culture that values diversity.