Manager Of Regulatory Affairs

Manager of Regulatory Affairs

Hybrid on-site role- candidates must be located in the DMV area.

Responsibilities:

• Leads and participates in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
• Coordinates across projects as needed to ensure harmonization and knowledge sharing.
• Coordinates the maintenance of work process tools to promote efficiency and productivity.? These may include templates, SOPs, work instructions, checklists, trackers, etc.
• Provides oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
• Supervises and manage Regulatory Team staff members, as assigned.
• Supports the preparation and review of technical proposals.
• Provides regulatory and project management support for projects as needed.
• Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
• Manages Regulatory Team(s) to manage the lifecycle of multiple drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), and to ensure compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
• Coordinates the tracking, compiling, and reviewing of regulatory submissions including, but not limited to New INDs, BLA, NDS, IDEs, Annual Reports to INDs and Protocol Reviews for accuracy, completeness and quality.
• Works closely with project management to mitigate/resolve issues and/or deviations from target timelines.
• Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.

Job Requirements:

• Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable.
• Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.
• General knowledge of the drug/vaccine development process or clinical trials is a plus.
• Ability to analyze medical research data and review experimental protocols.
• Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
• Experience in preparing regulatory documents, publishing regulatory submissions using electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
• Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
• 5-7 years of Regulatory Affairs experience.
• Superior organizational skills and customer service abilities.
• Strong working knowledge of Microsoft office; experience with SharePoint a plus.
• Bachelor's level education - Master's preferred