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Regulatory Compliance Manager

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 to ensure the effective management of various drug and biologic applications. This role is critical in maintaining compliance with Good Clinical Practices (GCP) and all relevant regulations set forth by regulatory health authorities.

Key Responsibilities

  • Lead the Regulatory Team in managing the lifecycle of Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), and New Drug Applications (NDAs).
  • Coordinate the preparation, tracking, and review of regulatory submissions to ensure accuracy and completeness.
  • Collaborate with project management to address and resolve any issues that may arise during the regulatory process.
  • Supervise and mentor regulatory team members, fostering a culture of excellence and compliance.
  • Engage in high-level communications with internal and external stakeholders, including regulatory authorities and clients.
  • Maintain and enhance work process tools to improve efficiency and productivity, including templates and standard operating procedures (SOPs).
  • Conduct literature reviews and participate in meetings to support regulatory document preparation and strategy.
  • Provide project management support as needed across various initiatives.
  • Ensure harmonization and knowledge sharing across projects to optimize regulatory practices.
  • Oversee the tracking of regulatory activities and maintain accurate records in compliance with regulatory standards.
  • Assist in the preparation and evaluation of technical proposals.

Qualifications

  • Exceptional verbal and written communication skills, with a keen attention to detail and the ability to manage multiple priorities.
  • Proven leadership and management experience, with a preference for candidates who have supervised teams or projects.
  • Strong organizational skills and a commitment to customer service.
  • Ability to analyze medical research data and review clinical protocols effectively.
  • Proficient in Microsoft Office; familiarity with SharePoint is advantageous.
  • A background in scientific fields, clinical trials, or regulatory affairs is preferred, along with knowledge of GCP and FDA regulations.
  • Experience in preparing regulatory documents and submissions, with proficiency in electronic publishing standards.
  • Demonstrated initiative and sound judgment in prioritizing projects.

We are an equal opportunity employer, dedicated to fostering a diverse 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.