Sr. Associate, Nonclinical Regulatory Specialist

Accountabilities
The Sr. Associate, Nonclinical Regulatory Specialist will serve as an operational partner supporting nonclinical regulatory activities, ensuring alignment between scientific objectives, regulatory expectations, and business priorities. Partner with nonclinical scientists, functional experts, and regulatory stakeholders to coordinate regulatory planning, document development, and submission readiness activities. Develop, maintain, and communicate integrated timelines for nonclinical regulatory deliverables, ensuring alignment with development milestones. Coordinate cross-functional execution of nonclinical regulatory packages and support teams in achieving quality and timely deliverables. Facilitate planning meetings, document decisions, track action items, and proactively follow up on commitments across stakeholder groups. Monitor project progress, identify risks or potential delays, communicate updates, and support mitigation strategies. Act as a day-to-day operational contact for assigned product teams, encouraging collaboration between scientific, regulatory, and operational functions. Ensure activities follow applicable regulatory requirements, internal quality standards, and established processes. Support the creation and maintenance of SOPs, templates, guidance materials, and operational documentation. Identify opportunities to improve regulatory workflows, communication processes, and operational efficiency. Contribute to continuous improvement initiatives, knowledge sharing, and adoption of digital tools, automation, and AI-enabled solutions. Requirements: The ideal candidate is a collaborative and organized professional with experience supporting scientific, regulatory, or pharmaceutical development activities, combined with strong project coordination capabilities. Master’s degree required, or equivalent experience through a Bachelor’s degree with 2 years of related experience, Associate degree with 6 years of related experience, or High School diploma/GED with 8 years of directly related experience. Experience supporting pharmaceutical research, biotechnology, life sciences, or nonclinical drug development programs preferred. Understanding of nonclinical development processes, regulatory documentation requirements, and global submission expectations. Experience coordinating complex cross-functional projects involving scientific and operational teams. Strong project management skills, including timeline development, milestone tracking, risk management, and meeting facilitation. Ability to build collaborative relationships and influence stakeholders without direct authority. Excellent organizational skills with the ability to manage multiple priorities in a fast-paced environment. Strong written, verbal, and interpersonal communication skills. Experience managing scientific or regulatory documents throughout their lifecycle. Familiarity with document management systems, collaboration platforms, and project management tools. Knowledge of Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and regulatory standards is preferred. Experience using digital technologies, automation tools, or AI-enabled solutions to improve operational effectiveness is a plus. Degree or advanced education in life sciences, regulatory affairs, business, or a related discipline preferred. Benefits: Competitive annual salary range of approximately $101,675 - $137,561 USD, depending on experience, qualifications, and location. 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. Life and disability insurance coverage. Flexible work models where applicable. Paid time-off programs supporting work-life balance. Opportunities for professional growth, learning, and career development within a collaborative environment.

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