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 manages 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 demonstrates 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. Please provide CV, salary requirements and writing sample to email@example.com
Required Education and Skills
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.