Regulatory Project Manager

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose -- moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart(R).

About the Role

We are seeking a Regulatory Project Manager to join our team in a remote capacity. As a Regulatory Project Manager, you will drive the operational execution of diverse regulatory projects that advance new treatments for patients. This position plays a key role in ensuring timely delivery of high-quality regulatory submissions, maintaining strict compliance, and building lasting client relationships. You'll collaborate with cross-functional teams, follow industry-standard processes, and contribute to regulatory strategy and execution from project initiation through successful completion.

Responsibilities include overseeing project scope and budget, managing timelines and deliverables, identifying and mitigating regulatory risks, and serving as the primary liaison between clients, internal stakeholders, and regulatory agencies. With diverse teams and continuous learning opportunities, the Regulatory Project Manager can explore career paths and expand skills across global regulatory affairs.

Key Responsibilities

• Oversee the operational execution of diverse regulatory projects and ensure timely delivery of high-quality regulatory submissions

• Manage project scope, budget, and timelines while maintaining strict regulatory compliance and quality standards

• Identify and mitigate potential regulatory risks while implementing proactive problem-solving strategies

• Collaborate closely with clients' teams, internal stakeholders, and regulatory agencies as the primary liaison and FDA representative

• Contribute to long-term strategic planning for clients' regulatory initiatives and drive continuous improvement in regulatory processes

• Facilitate interdisciplinary meetings, represent sponsors as US Agent when requested, and serve as the main contact for clients and internal stakeholders

• Build and maintain strong client relationships, identify new business opportunities, and support repeat business development

• Create and update project timelines, manage multiple complex projects simultaneously, and adapt to client-specific processes and cultures

Candidate Profile

You'll thrive in this role if you bring:

• Strong background in regulatory affairs and project management with proven track record of successful regulatory submissions

• Excellent organizational, leadership, communication, and stakeholder management skills

• Strategic thinking abilities with the capacity to translate regulatory insights into business opportunities

• Ability to adapt to client-specific processes and cultures while maintaining prompt communication and strong work prioritization

• Proactive approach to problem-solving, risk mitigation, and continuous process improvement

• Excellent customer service skills and the ability to influence and collaborate effectively across all organizational levels

Required Qualifications

• Bachelor's degree in a relevant scientific field

• Minimum of 3+ years in a regulatory affairs related project management role

• Demonstrated track record of successfully leading global regulatory projects and achieving key milestones

• In-depth knowledge of global regulatory requirements and processes across various therapeutic areas

• Excellent project management skills, including the ability to manage multiple complex projects simultaneously

• Outstanding communication and interpersonal skills with the ability to influence and collaborate effectively across all levels of the organization

• Proven leadership abilities, including experience in mentoring and developing team members

• Adaptability and resilience in navigating changing regulatory environments and organizational priorities

Preferred Qualifications

• Advanced degree (PharmD, PhD, or equivalent)

• Foreign language skills with fluency in Japanese, Chinese, or Korean

• Experience working in EST time zone or demonstrated ability to work EST hours from other US time zones

Location

Ideally candidates will be located in EST. Consideration, however, will be given to experienced Regulatory Project Managers within other US time zones who have the ability to work EST hours.

Benefits and Compensation

• Health, Vision & Dental Insurance

• Tuition Reimbursement

• Vacation/Holiday/Sick Time

• Flexible Spending & Health Savings Accounts

• Work/Life Balance

• 401(k) with Company match

• Pet Insurance

For a complete list of benefits, please visit

Parexel offers competitive salaries based on several factors, including the position and level offered, skills, education, training, experience, professional achievements, and location.

Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

We offer a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.