Regulatory Compliance Manager

1 week 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 to ensure the successful management of various drug and biologic applications, including Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), and New Drug Applications (NDAs). This role ensures adherence to Good Clinical Practices (GCPs), International Council for Harmonisation (ICH) guidelines, and all relevant regulations set forth by regulatory health authorities.

Key Responsibilities

  • Lead and manage the regulatory team to oversee the lifecycle of multiple regulatory submissions.
  • Coordinate the collection, organization, and evaluation of regulatory submissions for accuracy and completeness.
  • Collaborate with project management to address and resolve any issues that may arise during the regulatory process.
  • Supervise regulatory team members and provide guidance and support as needed.
  • Participate in and lead projects aimed at enhancing regulatory processes and promoting best practices.
  • Engage in effective communication with colleagues, clients, and regulatory authority representatives.
  • Maintain and improve work process tools to enhance efficiency and productivity.
  • Conduct literature reviews and attend relevant meetings to support regulatory document preparation and strategy.
  • Provide project management and regulatory support across various initiatives.
  • Ensure consistency and knowledge sharing across projects.
  • Oversee the tracking of regulatory activities and maintain accurate records.
  • Assist in the preparation and review of technical proposals.

Qualifications

  • Exceptional verbal and written communication skills, with a keen attention to detail and the ability to manage multiple priorities.
  • Strong leadership and management capabilities, with prior experience in team supervision preferred.
  • Excellent organizational skills and a commitment to customer service.
  • Ability to analyze clinical research data and evaluate experimental protocols.
  • Proficient in Microsoft Office; familiarity with SharePoint is advantageous.
  • Background in a scientific field, clinical trials, regulatory affairs, or healthcare; knowledge of GCP and experience in FDA-regulated environments is preferred.
  • Experience in preparing regulatory documents and familiarity with electronic submission standards.
  • Ability to exercise initiative and sound judgment while prioritizing ongoing 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.

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