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.
We have multiple career opportunities to join G&L’s core team of consultants in North America. We are looking for progressive and collaborative team members to work on a long term client engagement. The details of the client project are detailed below – but your role as a consultant may be varied and busy!
The location of these new headcounts can be very flexible and can be based anywhere, although we have offices in New Jersey, Florida, LA, San Diego and Boston.
Ensure all regulatory activities for assigned products are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Manage and Contribute to CMC projects, initiatives & actions along with prioritizing assigned workload appropriately.
Demonstrated ability to manage project activities, present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
Serve as CMC representative on a core project(s) demonstrating ability to manage project activities, assess regulatory risks & development plans to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
Manage regulatory issues, maintain submission information in relevant systems, tracks regulatory commitments & timelines for specific projects/products/markets with minimal supervision.
Serve as a technical and scientific resource within own work group/discipline and provides guidance for completion of difficult and complex projects.
Ensure all regulatory activities within the team are executed effectively & efficiently in compliance with external regulatory requirements & internal quality procedures.
Develop relationships with regulatory authorities to improve companies regulatory success
Serve as CMC representative on a core project(s), demonstrating ability to manage project activities, assess regulatory risks & development plans to contribute to develop global regulatory strategies for programs in accordance with regulatory, scientific & technical criteria.
Demonstrate ability to present and articulate issues for resolution and execute as a scientific/technical resource for assigned projects.
Technical discipline with 8+ years of experience in the pharmaceutical industry with relevant technical experience (QA, Technical Services, Operations, Manufacturing or R&D) and 3+ years pharmaceutical regulatory experience.
Minimum of 2+ years of hands-on CMC authoring experience (initial registrations or post-approval variations) is preferred.
Experience operating within GMP, GLP, or GCP related SOPs.
Product release system exposure helpful
Managing colleagues within a GCMC function, only if the position requires supervision of personnel.
3+ years management & supervisory experience with technical projects &/or staff
Bachelor’s degree or equivalent/graduate degree preferred in a pharmaceutical (Biology, Chemistry, Pharmacy or related science) &/or technical discipline.
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.