Regulatory Director, Galvani Bioelectronics

As Regulatory Director for Galvani Bioelectronics, you will provide worldwide direction on regulatory and clinical strategies for governmental approval to introduce new products and expanded therapies to market. You will provide advice, mentor Galvani associates on clinical and regulatory requirements, prepare and/or manage global submissions and negotiates their approval. You will also lead and/or assist with the training of less senior staff and provides work direction on projects of large scale.

The company

Galvani is a therapeutics R&D company formed in 2016 by GlaxoSmithKline and Verily Life Sciences to pioneer bioelectronic medicines - peripheral neuromodulation implants addressing disease with mechanistic and organ precision. With a long-term commitment from its parent companies at £600M subject to milestones, Galvani has a rare opportunity to impact medical practice and contribute to improved lives of a vast number of patients suffering from disease.

Since its inception, the company has rapidly built a novel implantable device platform uniquely geared towards abdominal, near-organ precision neuromodulation with minimally invasive implantation and user-centric patient and physician interfaces.

The company has chosen immunomodulation as its core focus, backed by strong preclinical and early clinical data. Its front-runner therapy for autoimmune diseases has shown highly differentiated effects in animal models of rheumatoid arthritis, safety and immunomodulatory effects in implanted large animals, target engagement in an intraoperative clinical study, and is followed by other transformative assets in earlier development. On the back of this progress, Galvani is now preparing chronic feasibility trials (equivalent to phase Ib/IIa) in RA starting in the US and UK later this year, including a randomised controlled trial accepted into the FDA Early Feasibility Program being the most critical one.

With a team of 50, split across UK and US, the company has a distinctly entrepreneurial culture where colleagues with diverse, outstanding talent are steeped in “can do” attitude, seeing no task too small or challenge too big, proactively seeking out accountability, and tirelessly driving the company forward. The motivation to make the most of the opportunity to pioneer new therapies and to create a special place to work is widely shared.

Embedded into GSK and Verily's R&D sites at Stevenage, South San Francisco, Upper Providence, and Research Triangle Park, Galvani is situated in major R&D hubs. Partnerships with GSK and Verily as well as a large number of external research teams, suppliers, and contract organisations are central to Galvani's business model where the in-house team is the integrator for the wider product and therapy development efforts.

The responsibilities:

• Adhere to Galvani's Core Beliefs and all safety and quality requirements including, but not limited to: Quality Management Systems (QMS), Environmental Management Systems (EMS), U.S. Food and Drug Administration (FDA) regulations, Company policies and operating procedures, and other regulatory requirements.
• Deliver and lead multiple regulatory/clinical programs, and drive business initiatives.
• Serve as the regulatory and potential clinical representative on a therapy team and oversee project plans and develop strategies to support projects
• Oversee and execute regulatory/clinical strategies,
• Implement regulatory and clinical plans
• Be responsible for the submission to regulatory agencies, including pre-submission and negotiation activities.
• Provide ongoing support to product development teams for regulatory and clinical issues and questions.
• Serve as regulatory/clinical consultant to marketing or research project teams and government regulatory agencies.
• Monitor and/or interpret changing regulations to assure compliance to regulations.
• Provide support to currently-marketed products as necessary. This includes reviewing labeling, promotional material, product changes and documentation for changes requiring government approval.

Required qualifications and experience

• Bachelor's degree in Engineering, Math or Statistics
• 12 years of regulatory experience medical device industry or pharmaceutical industry including US and international medical device regulatory submissions/approvals (FDA, MDD, AIMD, TGA, TPD, etc.)
• Experience with Class III/Implantable devices, PMAs, 510(k) and IDEs

Preferred, in addition:

• Proven leadership/credibility with Regulatory Agency personnel
• Proven expertise in all aspects of Regulatory Affairs: Strategy Planning, Submission Prep, All phases of FDA Device Law/Regulations, WW Reg and clinical requirements/procedures
• Strong technical writing skills

• Project management, team development, and influence management skills
• Knowledge of applicable laws which regulate medical device manufacturers
• Strong leadership skills with demonstrated ability to drive positive results
• Strong desire to mentor

Our mission and values

At Galvani, we transform patients' lives through pioneering precision neuromodulation therapies . We let our values guide what we do and how we do it

• We focus on the patient: we exist to change the lives of patients suffering from chronic diseases, achieve our mission with integrity and transparency, innovate for patient benefit, make decisions quickly and effectively, and work with urgency and agility because patients are waiting.
• We create solutions: we approach challenges energetically with an open and positive mind, have the courage and knowledge to take calculated risks, commit to a diverse, inclusive and sustainable environment, and strive for simplification wherever possible.
• We deliver through partnership: we work in collaborative relationships with mutual trust, internally and externally, integrate the best ideas and the best talent wherever they are found, build the best knowledge and solutions by sharing and constructively challenging, and invest in developing people and building capabilities.

*LI-GSK

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