Manager, Regulatory Affairs Clinical and Non-clinical (Remote)

Gaithersburg, MD

Posted: 07/12/2023 Industry: Scientific Job Number: 23-00303

Job Description

Manager, Regulatory Affairs Clinical and Non-clinical
Responsibilities include but are not limited to:
  • Support the coordination and preparation of timely regulatory submissions in accordance with applicable regulations
  • Coordinate with relevant functional groups and project team members to identify and gather required documentation and data needed for regulatory submissions
  • Review and quality control (QC) of nonclinical and clinical documents for compliance with regulatory requirements, such as clinical protocols, informed consent forms, investigator documentation, clinical and nonclinical study reports, among others
  • Assist with planning, authoring, reviewing and QC documents necessary to support regulatory submissions, including initial INDs/CTAs and maintenance (eg, protocol amendments, new investigators, annual reports), initial BLAs/MAAs and maintenance, meeting requests, briefing packages, and responses to queries from regulatory agencies
  • Review and QC regulatory submissions
  • Support initiation and maintenance of global regulatory filings for clinical trials
  • Maintain up-to-date working knowledge on relevant regulatory regulations, guidelines, and the current regulatory environment
  • Perform directed research for regulatory aspects of new drug development
  • Continuing professional development by attending regulatory-related meetings (eg, FDA Advisory Committee meetings, conferences, workshops)
  • Other duties as assigned

Education & Experience Requirements:
  • Bachelor' s degree or higher in biological or biomedical science
  • A minimum of 5 years of experience in Regulatory Affairs; however, demonstrated accomplishments within the industry may be evaluated and substituted for extent of regulatory experience, as applicable
  • Demonstrated understanding of the drug development process, particularly with vaccines or biologics
  • Working knowledge of US, EU, and other regulations and industry standards pertaining to regulatory requirements for drug/vaccine development
  • Ability to work independently and within a group setting and to interact effectively with different functional departments
  • Strong communication skills (oral, written, and interpersonal) and the ability to identify and recommend solutions to problems
  • Ability to discern areas of potential concern and communicate concerns effectively to manager

Key Skills and Competencies:
  • Able and willing to work in a fast-paced environment while managing multiple priorities
  • Flexible, detail-oriented, and possess excellent analytical and problem-solving skills
  • Shows strong initiative and drive; must be an organized self-starter
  • Knowledgeable in ICH CTD/eCTD structure and requirements
  • Excellent organizational skills
  • Excellent writing skills
  • Team-oriented, have good interpersonal, communication, and follow-up skills with strong attention to detail
  • Knowledge of MS Office with advanced MS Word skills

Meet Your Recruiter

Alan Slate

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