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Senior Regulatory Affairs Specialist

2 months ago

Bethesda, Maryland, United States HR Retail Full time
Regulatory Affairs Manager - (MGRRA_HR_RETAIL)

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Position Overview

The Regulatory Affairs Manager is responsible for overseeing the regulatory team and managing the lifecycle of various drug and biologic submissions. This role ensures adherence to Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) guidelines, and all relevant regulations set forth by health authorities.

Key Responsibilities

  • Lead and supervise the Regulatory Team to effectively manage Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), and Investigational Device Exemptions (IDEs).
  • Coordinate the preparation, tracking, and review of regulatory submissions, ensuring accuracy and compliance.
  • Collaborate with project management to address and resolve any issues impacting project timelines.
  • Oversee the development and maintenance of regulatory process tools, including templates and standard operating procedures (SOPs).
  • Engage in high-level communications with stakeholders, including regulatory authorities and internal teams.
  • Conduct literature reviews and participate in meetings to support regulatory documentation and strategy.
  • Provide project management support and ensure cross-project coordination for regulatory activities.
  • Maintain comprehensive records of regulatory activities and ensure database accuracy.
  • Assist in the preparation and evaluation of technical proposals.

Qualifications

  • Exceptional communication skills, both verbal and written, with a keen attention to detail.
  • Proven leadership abilities with experience in managing teams or projects.
  • Strong organizational skills and a commitment to customer service.
  • Ability to analyze clinical research data and assess experimental protocols.
  • Proficient in Microsoft Office; familiarity with SharePoint is advantageous.
  • Background in scientific fields, clinical trials, or regulatory affairs is preferred, with knowledge of GCP and FDA regulations.
  • Experience in preparing regulatory documents and submissions compliant with electronic standards.
  • Demonstrated initiative and sound judgment in prioritizing projects.

We are an equal opportunity employer, dedicated to fostering diversity in the workplace. All qualified candidates will be considered for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or veteran status.