Associate Director Regulatory Affairs

Company: Beacon Hill Staffing Group
Location: Boston
Posted on: September 17, 2020

Job Description:

This individual will operate in a high visibility role and will be responsible for representing Regulatory Affairs in cross-disciplinary project teams, developing, and coordinating regulatory strategies for assigned programs, and manage high-quality submissions to regulatory agencies.-- Essential Functions and DutiesSupport NDA/MAA (and other regions) dossier finalization by 1) providing regulatory guidance to cross-functional team; 2) managing deliverables to ensure documents are finalized in time to support submission activitiesSupport study related activities as need including but not limited to start up activities such as CTA compilation and submissions and close-out activities such as end of study notifications, study report submissionsSupport and/or lead in the preparation for regulatory agency meetings (e.g. US, EU, other global agencies)Write/review regulatory documents to support regulatory submissionsManage regulatory aspects of Phase 3 and other clinical trials concurrentlyCoordinate with internal and external partners for on-time delivery of high-quality regulatory submissions to regulatory agenciesEnsure compliance with regulatory requirements Skills and ExperienceBasic Qualifications: Master's degree 6 years pharmaceutical industry experience with 3 years in Regulatory AffairsBachelor's degree 8 years pharmaceutical industry experience 5 years in Regulatory AffairsPreferred Qualifications: Advanced degree in life sciencesExperience leading/working on regulatory submissions (e.g., INDs, briefing packages, NDA, MAA)Demonstrated evidence of writing of regulatory documents (e.g., Module 1, Module 2, briefing packages, response documents, pediatric plans, response documents, etc.)Knowledge of US, EU, and global regulatory requirementsStrong knowledge of drug developmentExcellent written and oral communication skillsExcellent interpersonal skillsStrong project management skills and drive for excellence

Keywords: Beacon Hill Staffing Group, Boston , Associate Director Regulatory Affairs, Executive , Boston, Massachusetts