Regulatory Affairs Associate

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.

Develop, publish, and support the publishing of regulatory submissions to global health authorities in alignment with established standards, requirements, and organizational commitments. Ensure all submissions are prepared in high-quality, compliant formats. Perform related activities as needed and provide support to both internal and external stakeholders.

Required Qualifications:

• 1–3 years of experience in regulatory publishing or document management within the pharmaceutical industry.
• Experience working with XML or other structured document formats.
• Foundational knowledge of eCTD structure and electronic submission requirements for global health authorities (FDA, EMA, Health Canada, etc.)
• Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms.
• Solid understanding of eCTD structure, submission standards, and applicable regulatory guidelines.
• Exceptional attention to detail with the ability to manage complex documentation and meet demanding timelines.

Preferred Qualifications:

• Familiarity with end‑to‑end submission lifecycle maintenance processes.
• In-depth knowledge of FDA and international regulatory agency requirements.
• Prior experience with document control or compliance‑driven workflows.
• Strong background in document preparation and formatting.

Skills:

• Proficiency in Microsoft Word and Adobe Acrobat for document formatting, hyperlinking, and submission preparation
• Ability to work effectively in a cross-functional team environment and manage multiple tasks under tight deadlines
• The ability to quickly learn new software tools and systems.
• Effective written and verbal communication skills

Education:

• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field (or equivalent work experience).