Regulatory Strategy Senior Associate

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.

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