CMC Regulatory Consultant

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.

Professional Excellence

• 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

Teamwork

• 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.