Thorough Group is partnering with an innovative clinical-stage biotechnology company developing novel therapies for patients with serious cardiovascular diseases.

The company is advancing a late-stage clinical development program and is seeking a (Senior) Manager, Regulatory Affairs to join its growing Regulatory organization.

This individual will be a key contributor to global regulatory strategy and submissions, with a primary focus on European Union and ex-U.S. Clinical Trial Applications (CTAs).

Reporting to senior Regulatory leadership, the (Senior) Manager will oversee CRO partners responsible for CTA preparation and execution, coordinate cross-functional regulatory deliverables, and manage health authority questions and responses.

This is an excellent opportunity for someone with strong EU CTR and CTIS experience who wants to make a meaningful impact within a lean, fast-moving clinical-stage biotech.

Key Responsibilities:

EU & Ex-U.S. Regulatory Submissions

• Manage the preparation, compilation, and submission of EU and ex-U.S. CTAs, including CTIS and country-specific submissions
• Coordinate CTA documentation, including protocols, Investigator's Brochures, IMPDs, informed consent forms, and supporting materials
• Provide regulatory guidance regarding EU CTR 536/2014, CTIS processes, and country-specific requirements
• Coordinate and manage health authority questions and sponsor responses
• Manage CTA lifecycle activities, including substantial modifications, protocol amendments, IMPD updates, quality changes, annual updates, and required notifications
• Track global submission activities and maintain accurate, inspection-ready regulatory documentation
• Support additional global regulatory submissions as programs advance
• Potentially contribute to U.S. IND activities and future NDA/MAA preparation

Cross-Functional & External Collaboration

• Partner closely with Clinical Development and Clinical Operations to support global clinical study start-up and development timelines
• Collaborate with CMC and Quality to ensure compliant IMPD and supporting quality documentation
• Manage and provide oversight of CROs and other external regulatory partners
• Serve as a Regulatory liaison across internal functions to drive timely and compliant submissions
• Identify regulatory risks and proactively develop solutions to keep programs moving forward

Required Experience

• Bachelor's degree in a scientific, regulatory, or related discipline
• 5+ years of Regulatory Affairs experience within biotechnology or pharmaceutical drug development
• Strong experience with EU and ex-U.S. clinical trial submissions
• Hands-on experience preparing and submitting EU CTAs through CTIS
• Strong knowledge of EU CTR 536/2014, EMA guidance, CTA requirements, and applicable ICH guidelines
• Experience managing CTA lifecycle activities, amendments, updates, and maintenance
• Experience interacting with health authorities and coordinating responses to regulatory questions
• Strong regulatory writing and document preparation capabilities
• Ability to manage CROs, external partners, timelines, and multiple concurrent priorities
• Strong project management and organizational skills
• Ability to work independently within a lean, fast-paced biotech environment
• Collaborative, proactive, and hands-on approach

Preferred Experience

• Advanced degree such as an MS, PhD, or PharmD
• Regulatory submission experience with the FDA and additional global health authorities
• Experience in markets such as the UK, Canada, Australia, South Korea, or Latin America
• Experience contributing to NDAs, MAAs, or other marketing applications
• Background in cardiovascular, rare disease, and/or small-molecule drug development
• Familiarity with ex-U.S. CMC regulatory requirements and IMPD quality documentation
• Experience with Veeva RIM or similar regulatory information/document management platforms

Why This Opportunity?

This is an opportunity to join a well-supported clinical-stage biotechnology company during an important period of global development.

The successful candidate will have significant ownership of EU and ex-U.S. regulatory activities and work directly with senior leadership and cross-functional development teams.

For Regulatory professionals who enjoy operating in a small, collaborative environment where they can remain hands-on and directly influence program execution, this represents an exciting next step.

Interested in learning more?

Contact the Thorough Group team for a confidential conversation about this opportunity.