Senior Associate, Nonclinical Regulatory Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Collaborate with nonclinical scientists, functional area representatives, and regulatory stakeholders to oversee nonclinical regulatory planning, document creation, and regulatory preparedness.

• Create, maintain, and convey integrated timelines for nonclinical regulatory documents and deliverables.

• Manage cross-functional activities and ensure the timely delivery of nonclinical regulatory packages.

• Organize planning meetings, document decisions, track action items, and follow up on commitments.

• Track progress, identify risks or delays, communicate issues, and assist in devising mitigation strategies.

• Act as the primary operational partner for designated product teams on a daily basis.

• Develop cooperative relationships across scientific, regulatory, and operational functions.

• Support the implementation of standard operating procedures, templates, job aids, and operational guidance documents.

• Recognize opportunities to enhance planning, coordination, communication, and operational efficiency.

• Engage in continuous improvement initiatives and contribute to knowledge sharing and departmental activities.

⛳️ Requirements

• Master's degree with 1 year of directly related experience, or Bachelor's degree with 5 years of directly related experience, or Associate's degree with 10 years of directly related experience.

• Relevant experience in pharmaceutical research and development, nonclinical sciences, regulatory affairs, scientific operations, program or project management, or other life sciences, biotech, or pharmaceutical fields.

• Experience in supporting pharmaceutical research and development or nonclinical drug development programs.

• Knowledge of nonclinical drug development, regulatory requirements, and nonclinical data and documentation for global regulatory submissions.

• Proven experience coordinating complex, cross-functional programs.

• Skills in project or program management, including timeline development, milestone tracking, risk management, and meeting facilitation.

• Ability to foster collaborative relationships and influence cross-functional teams without direct authority.

• Strong organizational skills and capability to manage multiple priorities effectively.

• Exceptional written, verbal, and interpersonal communication skills.

• Experience in coordinating scientific or regulatory documents throughout their lifecycle.

• Aptitude for improving operational processes, ideally utilizing AI/ML applications.

• Familiarity with document management systems, collaboration platforms, and project management tools.

• Desirable experience with digital technologies, automation tools, or AI-enabled solutions.

• Understanding of Good Laboratory Practice (GLP), Good Documentation Practices (GDP), and global regulatory expectations.

• Preferred educational qualifications include a Bachelor's or advanced degree in a life science discipline, regulatory affairs, business, or a related field.

• Sponsorship for this position is not guaranteed.

🏝️ Benefits

• Comprehensive employee benefits package.

• Retirement and Savings Plan with generous company contributions.

• Group medical, dental, and vision coverage.

• Life and disability insurance.

• Flexible spending accounts.

• Discretionary annual bonus program.

• Stock-based long-term incentives.

• Award-winning time-off plans.

• Flexible work models where feasible.

• Opportunities for career development.

• A collaborative culture that promotes professional and personal growth and well-being.