The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Biotechnology, Quality/Risk Management, US Regulatory Affairs, Worldwide Regulatory Affairs
4 Year Degree
We are excited to have an opening in G&L’s core team of consultants, based in the US. The role will be joining G&L’s leadership team, with responsibilities across the Gene and Cell therapy areas. G&L have a growing pipeline of ATMP client projects and this new position is in response to this uptick. The ideal candidate will have a strong background in regulatory affairs, with particular interest and experience working with cell and gene therapies. We are looking for strong technical expertise, but also someone who has a keen interest in building G&L’s footprint and team of consultants who work in this area.
Define strategies and provide tactical guidance to client’s biological/cell and gene therapy programs
Demonstrate ability to anticipate risks, be responsible for developing solutions to identified risks, discuss with team and management, and understand probabilities of technical success for the solutions
Prepare a target product profile (TPP) to guide the development plan and communicate product attributes to stakeholders
Build a regulatory strategy to facilitate successful pre-IND/IND meetings expedited programs (e.g., RMAT)
Serve as biologics/cell/gene therapy expert on business development calls; represent G&L Scientific at scientific conferences, industry events.
Anticipates, evaluates and implements trends and innovation in the gene and cell therapy area
Provides technical expertise and consulting to technical and business strategies.
Accountable for the development of organizational structure and capabilities of cell and gene therapy center of excellence service area.
Responsible for management of resourcing and budget planning for his/her area of focus
Provide leadership and development for direct reports
Our team of consultants are expected to be ambassadors for G&L – working directly with clients and Health Authorities – so therefore we really value communication skills and the art of negotiation and diplomacy.
All our staff are encouraged to have the confidence to speak their mind and suggest new ideas. All our consultants are expected to act as mentor to junior staff, contributing to the development of graduate and junior training programmes.
Above all, our company is all about our people – so you should have a passion for meritocracy, recognition and development.
We hope that you will feel excited about making suggestions or challenging existing methodologies! G&L’s reputation has been built on our customer service and client-focus – so any ideas that will help us stay ahead of the curve are encouraged!
Highly motivated leader with substantial experience in vector design and gene therapy drug development experience
Degree in science-related field, advanced degree appreciated
15+ years of regulatory experience required; biologics experience preferred
Prior managerial experience is also required.
Previous experience successfully leading an external collaboration (academic and/or industry) involving design of study plan, oversees execution and frequent evaluation of results to provide decision recommendations.
Diplomacy and positive influencing abilities with excellent communication skills
Referred experience in reviewing, authoring, or managing components of regulatory submissions
ability to understand and interpret complex scientific issues across multiple projects as it related to regulatory
Analytical and problem solving skills: ability to identify the critical issues of problems or opportunities using appropriate information; determines the causes and possible solutions to the problem
Strategic Implementation: ability to develop, implement and monitor the overall clinical operations strategy
Management of multiple tasks of varied complexity simultaneously
Ability to work in a demanding environment with aggressive project timelines
Additional Salary Information: Health Benefits, 401K and Bonus package
Internal Number: G_L2021
About G&L Scientific Inc
G&L Scientific provides consulting, staff augmentation, outsourcing and support services for Regulatory Affairs and Quality Assurance. With our own teams of experts based in our offices across Europe, Asia-Pacific and the US, as well as a pool of more than 2,500 global consultants, the key to G&L’s success is a straightforward, transparent approach; experience of unrivalled depth; and the recruitment and development of brilliant people. Indeed, the level of repeat business and ongoing long-term assignments is testament to the quality of service G&L provides.
Whether our client needs an individual RA professional or full project team, onsite or remote, G&L will design a custom solution that delivers significant savings and flexibility in line with operational demands.
As well as excellence in our chosen fields, we are renowned for the quality of our people. Our real success lies in recruiting and developing brilliant consultants. We seek the right individuals to match our business needs, then build the environment that allows them to fulfill their potential. People join G&L Scientific for a variety of reasons. Some want to work with the very latest developments in Clinical Res...earch & Regulatory Affairs, others want the opportunity to make a real difference working in a dynamic and pioneering team. Ultimately, G&L people are free-thinking, proactive and creative individuals who are not afraid of change.