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 will oversee the regulatory team responsible for managing the lifecycle of various drug and biologic applications, ensuring adherence to all relevant regulations and guidelines.

Location

Remote

Category

Regulatory Affairs

Job Type

Full-Time

Educational Requirements

Bachelor's Degree

Travel Requirements

None

Key Responsibilities

  • Lead the Regulatory Team in managing the submission process for Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), New Drug Applications (NDAs), and Investigational Device Exemptions (IDEs), ensuring compliance with GCPs/ICH and all applicable regulations.
  • Coordinate the tracking and reviewing of regulatory submissions, ensuring accuracy, completeness, and quality.
  • Collaborate with project management to address and resolve any issues or deviations from project timelines.
  • Supervise and mentor Regulatory Team members to foster professional development.
  • Participate in and lead projects aimed at optimizing regulatory processes and promoting best practices.
  • Engage in high-level communications with internal and external stakeholders, including regulatory health authority staff.
  • Maintain and enhance work process tools to improve efficiency and productivity, including templates and SOPs.
  • Conduct literature searches and attend relevant meetings to support regulatory documentation and strategy.
  • Provide regulatory and project management support as necessary.
  • Ensure harmonization and knowledge sharing across various projects.
  • Oversee the tracking of regulatory activities and maintain accurate records.
  • Assist in the preparation and review of technical proposals.

Qualifications

  • Exceptional oral and written communication skills; detail-oriented with strong multitasking abilities.
  • Proven management and leadership capabilities; experience in leading teams or projects is preferred.
  • Outstanding organizational skills and a commitment to customer service.
  • Ability to analyze medical research data and evaluate experimental protocols.
  • Proficient in Microsoft Office; familiarity with SharePoint is a plus.
  • Background in a scientific field, clinical trials, regulatory affairs, or healthcare; knowledge of GCP and experience in an FDA-regulated environment is advantageous.
  • Experience in preparing regulatory documents and familiarity with electronic submission standards.
  • Ability to exercise initiative and sound judgment while prioritizing ongoing projects.

We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

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