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Regulatory Affairs Consultant - Nonclinical Regulatory Writer (TALENT POOL)

, United States Date posted 08/11/2025 Job ID R0000034994

As part of Parexel Consulting, you will create and maximize value for clients throughout the product lifecycle. You will be a strategic guide in getting products to market faster, smarter – and keeping them there –your scientific, technical, regulatory, and/or commercial expertise will put best practice standards to work for biopharmaceutical and medical device companies large and small.

In return, you will be provided with interesting opportunities for growth and development and exposed to a variety of challenging assignments, product types, geographic regions, and therapeutic areas. Plus, as member of Parexel Consulting, you will enjoy all the advantages of working remotely, combined with access to the mentorship from a team of highly experienced regulatory professionals at the height of their careers. Join our team, and you will design solutions for the complexities of an ever-changing global marketplace.

Success Profile

Check out the top traits we're looking for and see if you have the right mix.

  • Detail-Oriented
  • Proactive
  • Problem-Solver
  • Results-Driven
  • Organized
  • Multi-Tasker

  • "When submitting major market applications, it’s key to ensure that the technical integrity of all data meets regulated requirement standards. Parexel makes this possible with a diverse team of seasoned professionals who care about getting important medicines to patients. This is Regulatory Operations at its best."

    Chris – Associate Director, Regulatory & Access

  • "In this role, I have had the unique opportunity to work with regulatory experts who are not only some of the most distinguished in their field, but are also some of the most compassionate people I know. I’ve been able to grow so much professionally by standing on the shoulders of giants!"

    Riley – Regulatory Affairs Consultant

Rewards

  • Global Impact

    We are one truly global team working together to propel each client´s journey ahead faster.

  • Balance

    We value work-life balance. We try and keep regular hours and an emphasis on life outside the office.

  • Collaboration

    Work with industry leaders and subject matter experts.

  • Freedom

    The ability to innovate, ask “what if” and try new solutions without fear of failure.

  • Variety

    Opportunities to work on multiple accounts – never boring!

  • Management

    Strong management with depth of experience working for global health authorities.

Responsibilities

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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Meet Stephanie: Director, Regulatory & Access

Stephanie is leading a team and providing regulatory consulting for a variety of medical device clients. In this interview, Stephanie talks about her role, the projects she works on, and her passion for helping clients address unmet medical needs. Learn More

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