Regulatory Strategy Senior Associate

About ParexelParexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.
About the RoleWe 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, and identifying key risks and opportunities, with opportunities to deepen your expertise and influence regulatory outcomes.
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.
Key Responsibilities
Develop and recommend regulatory pathways for assigned products, studies, or markets
Support agency engagement planning and prepare materials for regulatory meetings
Identify key regulatory risks and opportunities to inform development strategy
Align regulatory approaches with development and commercialization objectives
Maintain current knowledge of regulatory requirements and industry guidance
Collaborate with cross-functional teams to ensure regulatory compliance and strategic alignment
Prepare regulatory documentation and submissions as needed
Track regulatory timelines and milestones to support program execution
Candidate ProfileYou’ll thrive in this role if you bring:
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
Required Qualifications
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
We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.
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