Regulatory Affairs Senior / Consultant - Regulatory Lead (Home Based East Coast US or Canada)
United States of America, Remote Additional Locations Canada-Ontario-Remote; Job ID R0000032592 Category Consulting Date Posted 04/01/2025Overview
As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.
We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.
Success Profile
Do you have these soft skills and interpersonal traits to succeed at Parexel?
- Communicator
- Detail-oriented
- Problem-solver
- Relationship-builder
- Results-driven
- Strategic
About This Role
Are you a seasoned regulatory expert with a passion for guiding innovative pharmaceutical products through the complex landscape of clinical development? Parexel is seeking a dynamic and strategic Senior / Consultant - Regulatory Lead to join our team. In this pivotal role, you will lead regulatory submissions, ensure compliance with global regulations, and collaborate with multidisciplinary teams to bring groundbreaking therapies to market. If you thrive in a fast-paced environment and are eager to make a significant impact on global health, we want to hear from you!
As a Regulatory Affairs Senior / Consultant - Regulatory Lead, you will be responsible for:
Strategic and Operational Leadership:
Focus on clinical regulatory filings
Provide strategic and operational leadership on project teams
Support ongoing clinical development activities
Lead IND/CTA and BLA submissions for products in development and marketed products
Regulatory Knowledge and Application:
Integrate and apply knowledge of global regulations, with emphasis on US FDA regulations
Ensure compliance with pharmaceutical drug development regulations across quality, preclinical, and clinical programs
Monitor and interpret newly published FDA guidelines and international guidance documents
Provide training on applicable requirements for scientific staff as needed
Regulatory Strategy Development:
Develop regulatory strategies for assigned programs in collaboration with senior management
Analyze guidance and assess precedent information for similar indications
Obtain approval for activities supporting development and marketing objectives within specified timelines
Health Authority Communication:
Communicate with FDA and other health authorities for assigned programs
Manage regulatory activities associated with drug development programs
Submission Management:
Plan, prepare, and submit Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)
Manage IND amendments, annual reports, and other regulatory documents and correspondence
Ensure completeness and accuracy of all regulatory submissions
Multidisciplinary Team Collaboration:
Participate in and provide regulatory guidance to multidisciplinary project teams
Communicate regulatory goals and requirements to team members
Guide teams on content, format, style, and architecture of regulatory applications
Document Preparation and Review:
Edit or manage the editing of scientific sections of regulatory applications
Assist with writing, reviewing, and preparing regulatory documents
Perform critical analyses of clinical, preclinical, and manufacturing data
Develop independent interpretations and conclusions
Review clinical protocols and study reports to identify deficiencies or missing information
BLA-Specific Responsibilities:
Provide guidance on Biologics Licensing Application (BLA) preparation
Assist with scientific writing and review of BLAs
Evaluate BLA conformance with regulatory requirements
Qualifications:
Bachelors or Advanced degree in a scientific discipline (Ph.D. or equivalent preferred)
Minimum of 5+ years of experience in regulatory affairs in a similar capacity within the pharmaceutical or biotechnology industry
Extensive knowledge of global pharmaceutical regulations, particularly US FDA regulations. Depth of previous experience will determine Consultant or Senior Consultant level
Strong understanding of drug development processes and regulatory requirements with an emphasis on clinical module requirements
Excellent analytical, writing, and communication skills
Previous experience authoring Orphan Drug Designation Meeting packages
Ability to work effectively in multidisciplinary teams
Experience in managing regulatory submissions, preferably INDs and BLAs
Previous experience successfully leading cross functional teams in a deadline focused regulatory environment
Previous Biologics experience
Due to the nature of the role and client and team interaction, candidates located in the EST are highly preferred.
10-15% travel may be required
This position requires a detail-oriented individual with strong leadership skills, capable of managing complex regulatory processes and ensuring compliance with global pharmaceutical regulations.
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EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
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