Regulatory Affairs Consultant - Nonclinical Regulatory Writer (TALENT POOL)
Primary Location: United States, Remote Job ID R0000034994 Category Consulting Date Posted 08/11/2025Overview
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
We’re seeking to engage with experienced nonclinical regulatory writers who align with our mission and may be ideal candidates for upcoming home-based roles on Parexel's Regulatory Consulting team.
We are seeking a highly skilled Nonclinical Regulatory Writer with a strong foundation in authoring Module 2.4 (Nonclinical Overview) and Module 2.6 (Nonclinical Summaries) for global regulatory submissions. The ideal candidate will bring hands-on experience in animal study execution or oversight, and therapeutic expertise in neurology—with additional therapeutic areas to be confirmed.
This is a strategic writing role that blends scientific rigor with regulatory precision, supporting the development of innovative therapies in high-impact disease areas.
Key Responsibilities
Prepare and author nonclinical components of regulatory submissions (IND, NDA, BLA, MAA), with a focus on CTD Modules 2.4 and 2.6
Analyze and interpret data from pharmacology, toxicology, and ADME studies, including in vivo animal models
Collaborate with nonclinical scientists, regulatory strategists, and project teams to ensure scientific accuracy and regulatory compliance
Contribute to document planning, timelines, and strategy discussions
Ensure alignment with ICH guidelines and global health authority expectations
Participate in peer review and quality control of submission documents
Qualifications
Advanced degree in life sciences required: Master’s or PhD preferred (e.g., Pharmacology, Neuroscience, Toxicology, Biomedical Sciences)
4+ years of experience in nonclinical regulatory writing, including authoring eCTD Modules 2.4 and 2.6
Direct or supervisory experience in animal studies (e.g., study design, execution, or data analysis)
Therapeutic expertise in neurology preferred
Strong understanding of regulatory requirements (FDA, EMA, ICH)
Exceptional scientific writing, communication, and project management skills
Preferred Attributes
Experience supporting INDs, NDAs, or BLAs
Familiarity with global regulatory submission platforms
Ability to translate complex scientific data into clear, concise regulatory language
Collaborative mindset and ability to work cross-functionally
What We Offer
Opportunity to contribute to cutting-edge therapies in neurology and beyond
Flexible work environment with remote options
Supportive, science-driven culture
Career development and advancement opportunities
Join us in shaping the future of medicine.
Apply now to become a key contributor to our regulatory success.
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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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