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.
Biologics, Medical Device, Quality/Risk Management, US Regulatory Affairs
Dunn Regulatory Associates, LLC is looking for a Chemistry, Manufacturing, and Controls (CMC) consultant to join its team. This is a fully remote position, however, only applicants residing in Virginia, Maryland, District of Columbia and North Carolina will be considered.
Expertise in FDA regulated product CMC development
Expertise in Biologics and Small Molecules
Expertise in ex-US drug and device development a plus
Experience in writing and reviewing regulatory submissions, such as Pre-INDs, INDs, CTDs, or IMPDs
Works across all phases of development – from discovery to marketing applications
Understand the client’s problem; conceptualizes how to solve it and achieve task objectives
Contribute scientific and innovative thinking
Contribute significantly to a high quality work product acceptable to the senior consultant, on time and within budget
Effectively manage deadlines, and multi-tasks
Demonstrate excellent communication skills – written and oral.
Work well in a team environment
Participate in business development and expansion of existing business.
Promote and demonstrate collegiality with all firm members
May be responsible for the preparation of project plans, definition of tasks
Model, promote and demonstrate collegiality with all firm members
Personal Growth and Development
Maintain current scientific knowledge by initiating the appropriate internal or external educational/learning pursuits
Ensure personal development goals are in place and carried out in agreed timeframe
Knowledge of EU and US CMC guidances and laws
Dunn Regulatory offers a stimulating scientific and working environment that fosters professional growth and development. Very competitive salary and benefits package.
Advanced degree in a life science or related field of study, PhD in Chemistry preferred
Minimum of 3 - 5 years relevant experience
Excellent communication skills, both written and oral.
Internal Number: CMC01
About Dunn Regulatory Associates, LLC
Dunn Regulatory Associates, LLC is a full-service regulatory and product development consulting company for Rx and OTC pharmaceuticals, biopharmaceuticals, and devices. Our expert consultants are US and EU strategists, who have a proven track record of resolving even the most complex regulatory situations and can streamline product development from discovery to market.