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, Regulatory Compliance, US Regulatory Affairs
G&L have a number of opportunities for Regulatory professionals with a strong background in CMC. Our US team, which is based on both East and West coasts, has multiple projects with requirements in the coming months. Our projects are diverse and so we are considering all CMC talent for our upcoming openings, which will include consumer health, biotechnology or pharmaceutical products, as well as development and approved products.
Your responsibilities would include supporting, strategically developing and maintaining CMC timelines, providing evaluations of potential risks and conflicts, supporting the team on proactively resolving potential deviations, and presenting clear timeline reports.
You will be working in a team-orientated environment and will be empowered to drive CMC activities with minimal deviations, accelerating timelines and providing metrics to implement future enhancements.
Develop and maintain high quality, realistic, cross functional plans. The CMC consultant will develop timelines when the synopsis/draft protocol is available.
Develop and maintain high quality, realistic Chemistry, Manufacturing & Control (CMC) plans for products in development.
Partner with Project Management and Regulatory Affairs to implement project strategies and improve efficiency by identifying and implementing new business processes.
Partner with Pharmaceutical Sciences Strategy to ensure timely delivery of all CMC milestones.
You will be expected to identify gaps and risks in the CMC plans and work with the team and Management to proactively develop solutions which will increase efficiency and minimize timelines.
Define baselines and provide metrics to identify areas and trends that can be used by the teams for future enhancements.
Responsible for arranging and leading discussions on the clinical study and CMC plans.
Present clear CMC plan reports to stakeholders.
Operate within the Governance Board model for communication and accountability.
Provide continuous improvement on CMC plans and standard MS Project templates.
Additional Salary Information: We have a comprehensive benefits package including medical.
Internal Number: G_L2020
About G&L Scientific
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.