Regulatory Affairs Associate Publishing

Responsibilities

• Develop, publish, and support regulatory submissions to global health authorities in alignment with established standards and requirements
• Ensure all submissions are prepared in high-quality, compliant formats
• Perform related publishing activities and provide support to both internal and external stakeholders
• Manage complex documentation and meet demanding timelines for submission cycles

Requirements

• 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 (e.g., FDA, EMA, Health Canada)
• Proficiency with regulatory publishing systems such as Veeva, Extedo, Insight, DXC, or comparable platforms
• Proficiency in Microsoft Word and Adobe Acrobat for document formatting and hyperlinking
• Bachelor's degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field
• Excellent English communication skills (oral, written, and comprehension)

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

About the Company

Parexel is a global leader in clinical research, helping biopharmaceutical and medical device companies navigate complex regulatory landscapes. We are dedicated to advancing science with expertise and empathy, providing innovative regulatory strategies that bring life-changing products to market faster.