[Hiring] Regulatory Strategy Senior Associate @Parexel

Role Description

We are seeking a Regulatory Strategy Senior Associate to join our team in a remote capacity. As a Regulatory Strategy Senior Associate, you will support regulatory strategy initiatives that advance new treatments for patients. This position plays a key role in regulatory pathway planning, agency engagement support, and strategic compliance oversight. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy from planning through implementation.

Responsibilities include:

• Developing regulatory pathway recommendations
• Supporting agency engagement planning
• Identifying key risks and opportunities

You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through strategic regulatory guidance and product development support. With diverse teams and continuous learning opportunities, the Regulatory Strategy Senior Associate can explore career paths and expand skills across regulatory affairs and clinical development.

Qualifications

• Strengths in regulatory strategy, strategic thinking, and problem-solving
• Experience working in regulatory affairs, clinical development, or a regulated environment
• The ability to collaborate across teams and communicate clearly with internal and external stakeholders
• A patient-focused mindset and strong attention to detail
• Comfort working with regulatory databases, submission tracking systems, and standard office tools

Requirements

• Bachelor's degree in life sciences, regulatory affairs, pharmacy, or related field, or equivalent professional experience
• 4+ years of experience in regulatory affairs, clinical development, or a related field
• Previous experience with vaccine and/or biologic products is required
• FDA regulation expertise/knowledge is required and experience with other global markets is preferred
• Knowledge of ICH-GCP, regulatory requirements, and clinical trial processes
• Experience with regulatory databases or submission tracking systems
• Strong communication, organization, and problem-solving skills

Preferred Qualifications

• Advanced degree in regulatory affairs, pharmacy, or related field
• Experience in specific therapeutic areas or development phases
• Familiarity with regulatory submission software or electronic tracking systems
• Experience supporting FDA or international regulatory submissions

Benefits

• Flexibility in work environment
• Opportunities for growth
• Supportive team culture