Regulatory Strategy Senior Associate
About The Position
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.
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
- 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
Nice To Haves
- 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
- Experience with other global markets is preferred
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
Benefits
- Flexibility
- Growth opportunities
- Opportunities to do your best work
- Continuous learning opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Senior
