Regulatory Affairs Manager

1 week ago

Washington, United States Eliquent Life Sciences Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Manager to join our team at Eliquent Life Sciences. As a key member of our compliance and regulatory affairs department, you will play a critical role in ensuring that our clients' products comply with regulatory requirements and industry standards.

Key Responsibilities
  • Research and Analysis: Conduct research projects related to quality, compliance, and regulatory matters, under the guidance of directors and senior management.
  • Data Collection and Management: Facilitate the collection of relevant information and data for projects and reports, ensuring accuracy and relevance.
  • Reporting and Summaries: Draft summaries of project findings and analyses as requested, providing clear and actionable insights. Prepare, review, and manage regulatory documents, including submissions, reports, and compliance documentation.
  • Policy Tracking and Updates: Monitor and track policy changes and announcements related to the FDA regulatory landscape. Keep the team and clients informed of relevant updates and implications.
  • Editorial and Writing: Assist with editorial tasks, including researching, writing, reviewing, and editing regulatory documents and reports as needed. Ensure that all content meets regulatory standards and client requirements.
  • Client Engagement and Support: Engage with current and prospective clients, providing support and contributing to discussions on regulatory matters. Work directly with clients to understand their needs, address their concerns, and offer expert advice on navigating regulatory challenges.
  • Project Management: Manage multiple regulatory projects concurrently, ensuring timely completion and adherence to client specifications and regulatory requirements. Coordinate project activities, track progress, and resolve any issues that arise.
Qualifications
  • A graduate degree is required. A Juris Doctorate, Master of Public Health, or Doctor of Pharmacy is a plus.
  • A solid understanding of the U.S. healthcare system and a basic grasp of the FDA's regulatory role.
  • Experience in research, analysis, project management. Prior experience in regulatory consulting or related fields is a plus.
Skills
  • Strong analytical skills with the ability to interpret and apply complex information.
  • Proficiency in gathering and organizing data effectively.
  • Skill in preparing, reviewing, and managing documents and reports.
  • Excellent written and verbal communication skills for client interaction and documentation.
  • Ability to manage multiple projects efficiently and meet deadlines.
  • Public speaking skills
What We Offer
  • Competitive Compensation: Attractive salary and comprehensive benefits package for full-time employees, including health, dental, vision, and life insurance, a 401(k) plan with employer match, a generous paid time off policy, and additional perks.
  • Career Development: Opportunities for professional growth and advancement within a supportive and innovative environment.
  • Flexible Work: Hybrid work arrangement offering flexibility to work both remotely and on-site.
  • Work-Life Balance: Flexible work arrangements and a commitment to maintaining a healthy work-life balance.

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