Sr. Associate, Nonclinical Regulatory Specialist

📋 Description

• Coordinate nonclinical regulatory activities across product lifecycle to ensure readiness for
• Partner with scientists, regulatory experts, and cross-functional stakeholders to deliver
• Manage timelines, communications, and deliverables to translate regulatory strategies into
• Provide operational support bridging scientific, regulatory, and operational functions.
• Develop and maintain SOPs, templates, and guidance materials; drive process improvements.
• Monitor progress, identify risks, and support mitigation strategies to maintain timely deliverables.

🎯 Requirements

• Master’s degree required, or equivalent combination of education/experience; or Bachelor’s with 2
• Experience supporting pharmaceutical research, biotechnology, life sciences, or nonclinical drug
• Understanding of nonclinical development processes, regulatory documentation requirements, and
• Experience coordinating complex cross-functional projects; strong project management
• Ability to build collaborative relationships and influence stakeholders without direct authority.
• Excellent organizational and multi-tasking skills; strong written/verbal/interpersonal

🎁 Benefits

• Competitive annual salary range of approximately $101,675 - $137,561 USD, depending on experience
• Comprehensive healthcare benefits, including medical, dental, and vision coverage.
• Retirement savings plan with company contributions.
• Flexible spending account options and financial wellness resources.
• Annual bonus opportunities based on eligibility.
• Stock-based long-term incentive opportunities.