Regulatory Affairs Manager

JOB DESCRIPTION

Piper Clinical Solutions is seeking a motivated Regulatory Affairs Manager in Bethesda, MD to support an established research firm supporting both commercial and government clients with ongoing clinical research trials.

Responsibilities for the Regulatory Affairs Manager:

·       Manage and oversee the Regulatory teams to manage lifecycle of drug and IND applications and to ensure compliance with ICH, GCP and all other regulatory bodies

·       Supervise and oversee Regulatory teams

·       Coordinate and maintain the tracking and reviewing of regulatory submissions including annual reports, IND applications, informed consent forms, protocol reviews and review for accuracy and completeness.

·       Lead and participate in projects to optimize regulatory processes

·       Collaborate with Project Management team to alleviate and resolve issues to meet expected timelines.

·       Participate in meetings with clients, colleagues, regulatory and pharma staff as appropriate.

·       Coordinate the maintenance to promote optimization of productivity – check lists, SOPs, trackers

·       Provide support in the preparation of regulatory documentation, strategy and perform literature searches

·       Oversee the tracking of Regulatory teams productivity, activity, maintenance of electronic databases and ensure all records are compliant, complete and accurate.

Requirements for the Regulatory Affairs Manager: 

·       3+ years of experience in a regulatory environment managing and submitting regulatory documentation for clinical trials (IRB/GCP/FDA)

·       Advanced knowledge of medical terminology

·       Working knowledge of database management programs, analytical tools, and CTMS

·       Ph.D. in science-related field preferred, Master’s Degree accepted

Compensation for the Regulatory Affairs Manager:

·       Salary up to $115k based on experience

·       Benefits: Health, Dental, & Vision insurance and 401K

Please send all qualified resumes to: bnoell@pipercompanies.com

Keywords:

Good Clinical Practice, GCP, IRB, international review board, manager, regulatory manager FDA, pharmacology, toxicology, biochemistry, biology, chemistry, immunology, clinical trials, ICH, regulatory documents, data management, tmf