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Regulatory Affairs Consultant - Regulatory Generalist
Primary Location: United States, Remote Job ID R0000040429 Category Regulatory Affairs Date Posted 04/07/2026
Overview
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
We are seeking a highly organized and collaborative Regulatory Affairs Generalist to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities.
Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes.
The Regulatory Affairs Generalist provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills.
Key Responsibilities
1. Regulatory Archiving & Documentation Management
Maintain U.S. regulatory archive logs, including:
Recording new submissions.
Archiving regulatory authority correspondence.
Upload and manage correspondence from global partners for assigned programs.
Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools.
Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations.
2. Clinical Regulatory Support
Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation.
Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance.
Author 1572 waiver requests and support routine regulatory submissions for clinical investigators.
Attend cross functional clinical trial team meetings as the Regulatory Affairs representative, providing regulatory interpretation, updates, and risk assessments.
3. Regulatory Submission Preparation
Draft administrative components of regulatory submissions, including:
FDA forms
Cover letters
Submission metadata and other supporting documents
Build and organize electronic submission structures using RIM systems or industry standard submission planning tools.
Manage internal workflows and approval processes to ensure timely completion of submission components.
Coordinate submission package delivery through established publishing workflows and oversee communication with submission/publishing teams.
4. Global Regulatory Team (GRT) & Cross Functional Collaboration
Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings.
Serve as the Regulatory Affairs representative in partner or alliance meetings for assigned products, providing updates and tracking action items.
Support ongoing cross functional program meetings as needed, ensuring regulatory deliverables and timelines remain on track.
5. Authoring & Reviewing Regulatory Submissions
Contribute to the drafting, review, and preparation of regulatory submissions across development phases, including:
FDA meeting requests
Briefing documents
Applications for special regulatory designations (e.g., Fast Track, Orphan Drug Designation)
IND submissions, amendments, and associated documentation
Ensure content is scientifically sound, consistent, clear, and aligned with regulatory standards and internal templates.
6. Post Approval Regulatory Maintenance
Prepare, review, and submit periodic post marketing regulatory reports for assigned products, including:
PADERs (Periodic Adverse Drug Experience Reports)
NDA Annual Reports
DSURs (Development Safety Update Reports)
PBRERs (Periodic Benefit Risk Evaluation Reports)
Maintain tracking and compliance with global post approval commitments, submission deadlines, and regulatory requirements.
Support lifecycle management activities to ensure continued product compliance.
Skills:
Project management knowledge
Client-focused approach to work
Results orientation
Teamwork and collaboration skills
Consulting skills
Excellent interpersonal and intercultural communication skills, both written and verbal
Critical thinking and problem-solving skills
Proficiency in local language and extensive working knowledge of the English language
Knowledge and Experience:
5+ years of related regulatory affairs experience in an industry-related environment
Education:
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred.
Other:
Due to the client’s location, candidates located in the Eastern or Central time zones of the US or Canada are preferred.
The ability to travel up to 20% may be required.
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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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