Senior Director, Regulatory Affairs

Join Beacon Therapeutics (USA) Inc. as a Full-Time Senior Director of Regulatory Affairs and be at the forefront of transformative biotech innovations. This is a unique opportunity to shape regulatory strategies that directly influence the success of groundbreaking therapeutics in the UK market. Here, you will have the chance to leverage your expertise in a supportive environment that values accountability, integrity, and continuous improvement.

This role empowers you to lead significant projects and make impactful decisions that drive our mission forward. You will be provided great benefits such as Medical, Dental, Vision, Life Insurance, and Paid Time Off. Join us in fostering a diverse and respectful workplace where every idea is valued, and together we strive to achieve excellence. Don't miss the chance to elevate your career at Beacon Therapeutics.

Let us introduce ourselves

If you're passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We're a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.

Your day as a Senior Director, Regulatory Affairs - UK Remote

As the Senior Director of Regulatory Affairs at Beacon Therapeutics, you will provide essential regulatory leadership to support the development, registration, and lifecycle management of our innovative pipeline products. This role involves formulating strategic regulatory direction, including the creation of comprehensive regulatory plans, assessing clinical study requirements, and managing marketing approvals. You will spearhead the EU UK Marketing Authorization Application (MAA) filing for our lead program, Laruparetigene zovaparvovec, overseeing the execution of filing strategies and interactions with Health Authorities. Serving as the primary liaison with the EMA and MHRA, you will coordinate all regulatory submissions and ensure compliance with post-inspection commitments.

Your expertise will guide internal project teams by reviewing and approving regulatory documents, identifying deficiencies, and leading resolution efforts. By monitoring changes in the global regulatory landscape, you will evaluate their impact on our product development, all while fostering a collaborative and transparent culture within the company.

Requirements for this Senior Director, Regulatory Affairs - UK Remote job

To excel as a Senior Director of Regulatory Affairs at Beacon Therapeutics, candidates must possess significant hands-on experience in regulatory affairs, typically spanning over seven years. Proven expertise in leading EU and UK New Medicines Evaluations (NME) filings is essential, accompanied by extensive experience navigating the strategic and operational aspects of regulatory affairs within these markets. A strong understanding of EU and UK regulatory frameworks is critical for interpreting regulations and assessing the broader regulatory environment effectively. Candidates should demonstrate exceptional leadership, teamwork, and collaboration capabilities, particularly in biologics development and registration, with a preference for those with gene therapy and ophthalmology experience.

Success in this role also requires strong negotiation and problem-solving skills, along with strategic thinking and influencing capabilities. Proficiency in ICH guidelines and international drug submissions, including IND, GLP, GMP, GCP, and QMS systems, is vital. Experience managing multidiscipline project teams within regulated industries will further enhance effectiveness in this critical position at Beacon Therapeutics.

Knowledge and skills required for the position are:

• Significant hands on experience in regulatory affairs (typically 7+ years)
• Proven experience leading EU and UK NME filings
• Extensive strategic and operational EU and UK regulatory affairs experience
• Strong understanding of EU and UK regulatory frameworks and ability to interpret regulations and the broader regulatory environment
• Demonstrated leadership teamwork and collaboration capabilities
• Experience in biologics development manufacturing and registration with gene therapy experience preferred
• Ophthalmology experience preferred
• Regulatory experience with clinical trials
• Strong negotiating and problem solving skills
• Strong strategic thinking and influencing skills
• Working knowledge of ICH and international drug submissions and manufacturing requirements including IND GLP GMP GCP and QMS systems
• Working knowledge of FDA drug submissions and the US regulatory environment preferred
• Experience in project management of multidiscipline teams in regulated industry

Connect with our team today

We believe in taking care of our team, both on and off the job. That's why we offer a mobile-friendly application process - because we know your time is valuable. If you're ready to take your management skills to the next level and join a team that values hard work and good times, complete our application today

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