Dunn Regulatory Associates, LLC is seeking a full-time Submission Level Publisher with docuBridge experience. The successful candidate should demonstrate professional excellence in the following:
Preparation of documents for publishing, compilation, and QC of regulatory submissions to Regulatory Health Authorities (e.g., FDA and EMA), including but not limited to IND, BLA/NDA/MAA, IND amendments, meeting requests and briefing books.
Knowledge of eCTD templates and structure of Modules (1-5).
Experience with Lorenz docuBridge software, minimum of 3 years.
Word formatting, PDF publishing and eCTD backbone compilation of regulatory submissions.
Assures completeness and quality of submissions from the operations perspective.
Identifies issues, suggests and implements solutions.
Proper archiving of regulatory submissions.
Knowledge of current regulations, laws and guidance both US and ex-US.
Responsible for interaction with team across a number of development programs.
Interface with project managers, regulatory leads, and/or content authors to provide technical guidance and support in finalizing submission content.
Promote and demonstrates collegiality with all firm members.
Experience with docubBridge software, minimum of 3 years, is a must.
Extensive knowledge of IND/BLA/eCTD and other electronic requirements and guidelines.
Excellent interpersonal communication, both oral and written.
Excellent organizational skills.
Ability to work with strict deadlines, changing requirements and changing priorities.
Experience in working with vendors in support of regulatory submissions.
A minimum of a BS in Chemistry or Life Sciences.
A minimum of 3 years pharmaceutical and/or medical device industry experience.
A minimum of 3 years of regulatory affairs in FDA regulated products.
Must be detail oriented and able to handle multiple projects concurrently.
Telecommuting is allowed.
Additional Salary Information: Dunn Regulatory Associates, LLC offers competitive remuneration and a full benefits package.
Internal Number: REGOPS01
About Dunn Regulatory Associates
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.