Regulatory Affairs Consultant - Nonclinical Regulatory Writer (TALENT POOL)

Nonclinical Regulatory Writer

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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 neurologywith 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

Preferred Attributes

What We Offer

Join us in shaping the future of medicine.

Apply now to become a key contributor to our regulatory success.

EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.