Regulatory Strategy Senior Associate

Job summary

The Regulatory Strategy Senior Associate will develop regulatory pathway recommendations and support agency engagement planning for clinical products. They will also identify key regulatory risks and opportunities while ensuring compliance across cross-functional teams.

Job details

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. Please note - This position is part of a talent pool created in anticipation of future opportunities within our Regulatory team. Candidates may be considered for upcoming roles as business needs evolve. About Parexel Parexel 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. We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart. About the Role 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, 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 Profile You'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 If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply! 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. #LI-LB1

What you’ll do

The Regulatory Strategy Senior Associate will develop regulatory pathway recommendations and support agency engagement planning for clinical products. They will also identify key regulatory risks and opportunities while ensuring compliance across cross-functional teams.

Requirements

Candidates must hold a bachelor's degree in a life sciences or related field and possess at least 4 years of experience in regulatory affairs or clinical development. Expertise in FDA regulations and experience with vaccine or biologic products are mandatory requirements.

Listed skills

• Problem solving · Preferred
• Organization · Preferred
• Attention to detail · Preferred
• Communication · Preferred

Other relevant skills

Identified from the job description. Confirm important requirements above.

• Regulatory strategy
• Regulatory affairs
• Clinical development
• FDA regulation
• Strategic planning
• Agency engagement
• Compliance oversight
• Risk assessment
• ICH-GCP
• Submission tracking
• Regulatory documentation
• Cross-functional collaboration
• Problem-solving
• Communication
• Organization
• Attention to detail
• Regulatory Affairs
• Regulatory Documents
• Empathy
• Influencing Skills
• Continuous Development
• Influencing Without Authority
• Planning
• Research
• Biopharmaceuticals
• Pre-Clinical Development
• Clinical Research
• Clinical Trials
• Commercialization
• Regulatory Compliance
• Consulting
• Global Marketing
• Good Clinical Practices (GCP)
• Innovation
• Problem Solving
• Life Sciences
• Milestones (Project Management)
• New Product Development
• Strategic Alignment
• Strategic Thinking
• Timelines
• Collaboration
• Detail Oriented

Job areas

• Healthcare
• Science & Research
• Consulting
• Regulatory Associate
• Regulatory Affairs Specialist
• Legal Professionals Not Elsewhere Classified
• Regulatory Affairs Specialists
• Compliance Officers