Senior Vice President, Regulatory Affairs And Quality

Exciting opportunity for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory strategy and Quality systems for cutting-edge biotech projects at Beacon Therapeutics. As a pivotal member of our team, you will have work from home flexibility. You will have the chance to work on a best-in-class late-stage gene therapy program to treat X-Linked Retinitis Pigmentosa (XLRP). This role will be the key interface with FDA/EMA, responsible for preparing BLA/MAA submission, and part of the executive management team reporting to the CEO. At Beacon Therapeutics, you will make a significant impact on the industry and thrive in a flexible work environment while driving the company's mission forward. With competitive compensation and benefits that matches your expertise and skills, this role offers a fulfilling career path for those seeking to excel in Regulatory Affairs and Quality management. Join us in revolutionizing the biotech field and shaping the future of medicine.

BEACON THERAPEUTICS: OUR STORY

Beacon Therapeutics is Syncona's latest investment in the AAV ophthalmic gene therapy space following the successful exits of Nightstar and Gyroscope Therapeutics. In November of 2022, Syncona acquired AGTC (Applied Genetic Technology Corporation) and its lead clinical candidate for X-Linked Retinitis Pigmentosa. This has been combined with new IP from the UK life sciences ecosystem to create the new company, Beacon Therapeutics.

In March 2023, Syncona and partners successfully raised substantial funding for the clinical and pre-clinical candidates targeted to saving and restoring vision in patients with blinding retinal diseases. Beacon Therapeutics has established facilities in the US and a new UK facility in Kings Cross, London.

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 (Boston, MA and Alachua, FL) and the UK (London), 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.

MAKE A DIFFERENCE AS A SENIOR VICE PRESIDENT, REGULATORY AFFAIRS AND QUALITY

As the Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, you will play a crucial role in shaping the company's trajectory by leading the Regulatory and Compliance strategy. Your innovative solutions and strategic insights will drive the Regulatory and Quality Group towards excellence, ensuring adherence to all compliance standards. This position offers a unique opportunity to make a significant impact on the biotech industry while fostering a culture of continuous improvement and integrity within the organization. Join our forward-thinking team and be at the forefront of groundbreaking developments that are revolutionizing healthcare.

Apply now to be part of this exciting journey!

ARE YOU A GOOD FIT FOR THIS SENIOR VICE PRESIDENT, REGULATORY AFFAIRS AND QUALITY JOB?

To excel in the role of Full Time Senior Vice President, Regulatory Affairs and Quality at Beacon Therapeutics, proficiency in IND and CTA regulatory processes, as well as a deep understanding of the regulatory frameworks in the US and EU, is essential. Familiarity with Gene therapy, ophthalmology, and Quality management requirements is crucial for successful project execution. Strong negotiation and influencing skills, coupled with strategic thinking and a solution-oriented mindset, are key attributes needed to navigate complex regulatory landscapes effectively.

Clear and adaptive communication, exceptional leadership abilities to develop and manage teams, and a collaborative approach to fostering a compliant culture are critical. The ability to consistently deliver high-quality results on time and to specifications is paramount in driving the company towards its goals.

Knowledge and skills required for the position are:

• IND and CTA regulatory processes
• regulatory framework in US and EU
• Gene TA
• ophthalmology
• requirements for quality management
• negotiation and influencing skills
• strategic thinking
• solution oriented
• flexible
• clear communication adapted to audience
• people skills
• develop staff
• lead/manage team and establish collaborative and compliant culture
• deliver high quality work in a timely manner

OUR TEAM NEEDS YOU!

If you think this full-time job is a fit for what you are looking for, applying is a snap - just follow the instructions on this page. Location for this role is flexible. Good luck!