Dunn Regulatory Associates, LLC is looking for a highly skilled Regulatory Affairs professional to join its team. This is a fully remote position, however, only applicants residing in Virginia, Maryland, District of Columbia or North Carolina will be considered.
Develop regulatory strategy for projects including creative solutions to complex problems
Knowledge of current regulations, laws and guidance both US and ex-US
Ability to take a leadership position on project teams
Responsible for interaction with team across a number of development programs
Independent planning, coordination and preparation of document packages for regulatory submissions, such as Pre-IND meeting requests and packages, INDs, CTDs, EOP2, and/or position papers
Independently initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, up to and including travel to, and direct discussions with the appropriate regulatory agency
Provide project, department, and company guidance and training based on current and emerging FDA regulatory affairs requirements, regulations, and processes, and focus on improved regulatory efficiency and effectiveness
Demonstrate excellent technical/medical/biomedical written and oral communication skills
Capable of developing and adhering to timelines
Promote and demonstrates collegiality with all firm members
Participates in the training and development programs
Dunn Regulatory offers a stimulating scientific and working environment that fosters professional growth and development. Very competitive salary and benefits package.
A minimum of 6-8 years pharmaceutical and/or medical device industry experience
A minimum of a BS in Chemistry or Life Sciences
A minimum of 4 years of regulatory affairs in FDA regulated products
RAPS certification preferred
Excellent communication skills, both oral and written, with proficiency in MS Word, Excel, PowerPoint, and Project required
Must be organized, team oriented, detail oriented, and able to handle multiple projects concurrently
Telecommuting is allowed.
Internal Number: AD01
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.
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