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Senior Regulatory Affairs Specialist

2 months ago

Bethesda, Maryland, United States HR Retail Full time
Regulatory Affairs Manager - 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 submissions, including Investigational New Drug Applications (INDs), Biologics License Applications (BLAs), and New Drug Applications (NDAs). This role is crucial in maintaining compliance with 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 submissions, ensuring adherence to regulatory standards.
  • Coordinate the compilation, tracking, and review of regulatory submissions to guarantee accuracy and completeness.
  • Collaborate with project management to address and resolve any issues or deviations from established timelines.
  • Supervise regulatory team members, providing guidance and support as necessary.
  • Participate in and lead projects aimed at enhancing regulatory processes and implementing best practices.
  • Engage in effective communication with internal and external stakeholders, including regulatory authorities and clients.
  • Maintain and optimize work process tools to enhance efficiency, including templates and standard operating procedures (SOPs).
  • Conduct literature reviews and attend relevant meetings to support regulatory documentation and strategy.
  • Provide regulatory and project management assistance as required across various projects.
  • Ensure harmonization and knowledge sharing across projects to promote best practices.
  • Oversee the tracking of regulatory activities and maintain accurate records in databases.
  • Assist in the preparation and evaluation of technical proposals.

Qualifications

  • Exceptional oral and written communication skills, with a keen attention to detail and the ability to prioritize effectively.
  • Proven leadership and management capabilities, with experience in supervising teams or projects.
  • Strong organizational skills and a commitment to customer service excellence.
  • Ability to analyze medical research data and assess experimental protocols.
  • Proficient in Microsoft Office, with experience in SharePoint considered an advantage.
  • A background in scientific fields, clinical trials, or regulatory affairs is preferred, along with familiarity with GCP and FDA regulations.
  • Experience in preparing regulatory documents and utilizing electronic publishing software is essential.
  • Must demonstrate initiative, sound judgment, and the ability to manage multiple ongoing projects.

We are an equal opportunity employer, dedicated to fostering 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 veteran status.