Professional Excellence

• 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 and drive the project to completion as the project manager
• Ability to manage several projects at different stages of development
• Independent planning, coordination and preparation of document packages for regulatory submissions, such as meeting requests and briefing packages to support meetings with regulatory agencies, INDs/CTAs, and NDA/BLA/MAAs
• Knowledge of eCTD format
• 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 and/or clients
• 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

Teamwork

• Promote and demonstrates collegiality with all firm members.
• Participates in the training and development programs

Education and Skills

• A minimum of a BS in Regulatory Affairs (or similar) or Life Sciences
• A minimum of 5 years pharmaceutical and/or medical device industry, consulting, or regulatory agency experience
• A minimum of 4 years of regulatory affairs experience in regulated drugs, biologics, and device products
• RAPS certification preferred
• Excellent communication skills, both oral and written, with proficiency in MS Word, Excel, PowerPoint, and Project required. In addition, proficiency with SharePoint, eCTD templates, and Adobe products is required.
• Must be organized, team oriented, detail oriented, and able to handle multiple projects concurrently.

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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