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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