Regulatory Affairs Consultant - Nonclinical Regulatory Writer (TALENT POOL)

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.