Senior Regulatory Affairs Specialist

2 weeks ago

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

Position Overview

The Regulatory Affairs Manager will oversee the regulatory team to ensure compliance with industry standards and regulations. This role is crucial in managing the lifecycle of various regulatory submissions and maintaining high-quality standards throughout the process.

Key Responsibilities

  • Lead the Regulatory Team in managing the lifecycle of multiple regulatory submissions, ensuring adherence to Good Clinical Practices (GCP) and all relevant regulatory requirements.
  • 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 and mentor Regulatory Team members, fostering a collaborative and productive work environment.
  • Participate in projects aimed at optimizing regulatory processes and implementing best practices to enhance operational efficiency.
  • Engage in effective communication with internal and external stakeholders, including regulatory authorities and project teams.
  • Maintain and enhance work process tools to promote productivity, including templates, standard operating procedures (SOPs), and checklists.
  • Conduct literature reviews and attend relevant meetings to support regulatory document preparation and strategy.
  • Provide regulatory and project management support as needed across various projects.
  • Ensure harmonization and knowledge sharing across projects to maintain consistency in regulatory practices.
  • Oversee the tracking of regulatory activities and ensure that all records are maintained accurately and are up to date.
  • Assist in the preparation and review of technical proposals to support business objectives.

Qualifications

  • Exceptional oral and written communication skills with a keen attention to detail and the ability to manage multiple priorities.
  • Demonstrated leadership and management capabilities, with experience in guiding teams or projects.
  • Strong organizational skills complemented by excellent customer service abilities.
  • Ability to analyze scientific data and evaluate experimental protocols effectively.
  • Proficient in Microsoft Office, with experience in SharePoint considered an advantage.
  • Background in a scientific discipline, clinical trials, or regulatory affairs, with familiarity in GCP and FDA regulations being beneficial.
  • Experience in preparing regulatory documents and submissions, with proficiency in electronic publishing standards.
  • Capable of exercising initiative and sound judgment while prioritizing ongoing projects.

HR Retail is an equal opportunity employer committed 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.

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