Remote Regulatory Project Manager for Biotech Submissions

Parexel; Honolulu (HI); Remote; USD 120,000 - 170,000; Full time

Job summary

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will lead diverse regulatory projects for biotech clients, ensuring on-time, high-quality submissions and aligning with strategic regulatory plans.

Ideal candidates have 3+ years in regulatory affairs project management, strong leadership and stakeholder skills, and global regulatory knowledge. EST hours are preferred; remote, nationwide opportunities are available.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• 3+ years in regulatory affairs project management.
• Track record of global regulatory projects and milestones.
• Knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking to translate insights into opportunities.
• Excellent PM skills for multiple complex projects.
• Strong communication and interpersonal skills across all levels.
• Leadership experience in mentoring and developing teams.
• Adaptability in changing regulatory environments.

Responsibilities

• Oversee operational execution of diverse regulatory projects.
• Ensure timely delivery of high-quality regulatory submissions.
• Contribute to long-term strategic planning for clients' regulatory initiatives.
• Manage project scope and budget and identify risks.
• Collaborate with clients' teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Facilitate meetings as client and internal contact, and act as FDA liaison when requested.
• Build client relationships and pursue new and repeat business.

Skills

Regulatory affairs

Project management

Stakeholder mgmt

Leadership

Communication

Risk mgmt

Problem solving

Time management

Foreign language skills

Education

Bachelor's degree in a relevant field

Advanced degree (PharmD, PhD, or equivalent) preferred

Job description

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will lead diverse regulatory projects for biotech clients, ensuring on-time, high-quality submissions and aligning with strategic regulatory plans.

Ideal candidates have 3+ years in regulatory affairs project management, strong leadership and stakeholder skills, and global regulatory knowledge. EST hours are preferred; remote, nationwide opportunities are available.