Job Title
Regulatory Affairs Manager
Location
Bethesda, MD 20817 US (Primary)
Category
Regulatory Affairs
Job Type
Full-Time
Salary Range
100,000.00-120,000.00/YEAR
Education
Bachelor's Degree
Travel
None
Job Description
- 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.
- Supervises and manage Regulatory Team staff members, as assigned.
- Leads and participates in projects as assigned to optimize regulatory processes and facilitate best practice approaches to drive functional excellence.
- Effectively engage in high-profile communications and interactions with colleagues, collaborators, clients, regulatory health authority staff, and pharma staff as appropriate.
- Coordinates the maintenance of work process tools to promote efficiency and productivity.? These may include templates, SOPs, work instructions, checklists, trackers, etc.
- 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.
- Provides regulatory and project management support for projects as needed.
- Coordinates across projects as needed to ensure harmonization and knowledge sharing.
- Provides oversight for the tracking of regulatory activity, database maintenance, and ensure that records are complete, accurate, and current.
- Supports the preparation and review of technical proposals.
Job Requirements
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Strong management and leadership skills; experience leading/managing a team/project and/or supervising staff preferred.
- Superior organizational skills and customer service abilities.
- Ability to analyze medical research data and review experimental protocols.
- Strong working knowledge of Microsoft office; experience with SharePoint a plus.
- 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. General knowledge of the drug/vaccine development process or clinical trials is a plus.
- Experience in preparing regulatory documents, publishing regulatory submissions using?electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
- Must be able to exercise initiative and sound judgment, and to prioritize ongoing projects.?
