ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information about ELIQUENT, please visit our website at eliquent.com.
Position Overview:
As a Regulatory Affairs Manager at ELIQUENT, this individual will report directly to the Principal of Compliance and Regulatory Affairs. The primary function of this role will be to interface and support ELIQUENT’s product quality, manufacturing and compliance clients to ensure that their products comply with regulatory requirements and industry standards. The optimal candidate will need a firm understanding of the U.S. health care system and a basic understanding of the FDA’s role within the system. Additional responsibilities will involve research, analysis, writing, and managing multiple projects simultaneously. This role will also be a SME and responsible for representing the company at various conferences.
Key Responsibilities:
Research Support: Assist with research projects related to quality, compliance, and regulatory matters under the guidance of Directors and senior management.
Data Collection: 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: 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 Duties: 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: 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.
Expert Knowledge: Apply your understanding of the FDA’s role within the U.S. healthcare system to guide clients through regulatory processes and requirements. Stay current with FDA regulations and policies to provide informed advice.
Qualifications:
Graduate degree required. 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. Compensation is commensurate with professional experience.
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.
ELIQUENT Life Sciences is the leading global consulting firm providing solutions to life science companies researching, developing, and manufacturing innovative products to serve patients and respond to public health challenges around the world. ELIQUENT is committed to serving clients’ needs with extensive expertise, unwavering integrity, and strategic insight in a manner that supports availability of safe, effective, and high-quality drugs, biologics, and medical devices. For more information about ELIQUENT, please visit our website at eliquent.com.