Regulatory Project Manager

Parexel International; Northern (KY); Hybrid; USD 95,000 - 150,000; Full time

Job summary

Parexel International is expanding its Regulatory Project Management team with US-based, home-based roles for experienced Regulatory Project Managers. You will oversee regulatory projects, ensure timely submissions, and collaborate with clients and FDA liaison roles.

The role requires a strong background in regulatory affairs and project management, with leadership and client relationship skills. Ideal candidates will have 3+ years in regulatory affairs project management, a scientific degree,

Qualifications

• Bachelor's degree in a scientific field; advanced degree preferred.
• Minimum of 3+ years in regulatory affairs project management.
• Demonstrated track record leading global regulatory projects and milestones.
• Deep knowledge of global regulatory requirements across therapeutic areas.
• Strong strategic thinking and ability to translate regulatory insights into business opportunities.
• Excellent project management for multiple complex projects.
• Outstanding communication and interpersonal skills across all levels.
• Proven leadership and mentoring experience.
• Adaptable to changing regulatory environments and priorities.

Responsibilities

• Oversee the operational execution of diverse regulatory projects.
• Ensure timely delivery of regulatory submissions.
• Contribute to long-term strategic planning for regulatory initiatives.
• Manage project scope and budget.
• Identify and mitigate risks while ensuring compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes.
• Facilitate meetings with clients and act as FDA liaison as needed.
• Build client relationships and pursue new business opportunities.

Skills

Regulatory affairs

Project management

Organizational skills

Leadership

Communication

Stakeholder management

Risk mitigation

Client relationships

Work prioritization

Regulatory strategy

Education

Bachelor's degree in a scientific field

Advanced degree (PharmD, PhD, or equivalent) preferred

Tools

MS Project

Smartsheet

Job description

We are growing our Regulatory Project Management team, and we'd love to connect with experienced, proactive US-based Regulatory Project Managers.

These home-based roles are exciting opportunities to play a crucial role in driving regulatory success for our biotech clients while contributing to our company's growth.

In these pivotal roles, you will:

• Oversee the operational execution of diverse regulatory projects


• Ensure timely delivery of high-quality regulatory submissions


• Contribute to long-term strategic planning for the clients’ regulatory initiatives


• Be responsible for managing project scope and budget


• Identify and mitigate potential risks while maintaining strict regulatory compliance


• Collaborate closely with the clients’ teams and internal stakeholders


• Drive continuous improvement in regulatory processes and methodologies


• Facilitate interdisciplinary meetings as the main client and internal contact, as well as the FDA’s liaison, representing our sponsors as US Agent, as requested


• Build client relationships, gain new and repeat business

The ideal candidates will bring:

• Strong background in regulatory affairs and project management


• Excellent organizational skills


• Proven track record of successful regulatory submissions


• Previous experience creating and updating project timelines


• Excellent leadership, communication and stakeholder management skills


• Ability to adapt to client-specific processes and culture


• Prompt communication and a strong understanding of work prioritization and urgencies


• Excellent customer service skills


• Proactive approach to problem-solving and risk mitigation


• Foreign language skills are a plus with fluency in Japanese, Chinese, or Korean highly preferred

Qualifications:

• Bachelor's degree in a relevant scientific field; advanced degree (PharmD, PhD, or equivalent) preferred.


• 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.


• Strong strategic thinking skills with the ability to translate regulatory insights into business opportunities.


• 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.

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.

These roles offer the opportunity to partner with multiple clients and make significant contributions to their regulatory programs and, ultimately, providing new and/or better treatment options to patients. Plus, you'll be part of a growing team with potential for career advancement.

If you're ready to take on a challenging role that combines your regulatory expertise with strong project management skills in a client-focused environment, we want to hear from you. Join us in shaping the future of regulatory affairs and making a lasting impact on global healthcare through effective strategy and execution.

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.