Regulatory Affairs Project Management - various levels - US or Canada (Talent Pool)

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Regulatory Project Managers - Client FSP Program

Drive Regulatory Excellence in a Growing Partnership

Due to our ongoing success, we expect to be growing our North American Regulatory Project Management team!

In anticipation of these needs, we'd love to connect with experienced and proactive Regulatory Project Managers regarding an opportunity to join our team and partner with a large, dedicated client in our Functional Service Provider (FSP) Program. These roles are exciting opportunities to play a crucial role in driving regulatory success for a key client 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 client's regulatory initiatives

• Identify and mitigate potential risks while maintaining strict regulatory compliance

• Collaborate closely with the client team and internal stakeholders

• Drive continuous improvement in regulatory processes and methodologies

• Facilitate interdisciplinary meetings

The ideal candidates will bring:

• Strong background in regulatory affairs and project management

• Excellent organizational skills

• Proven track record of successful regulatory submissions

• Excellent communication and stakeholder management skills

• Ability to adapt to client-specific processes and culture

• Proactive approach to problem-solving and risk mitigation

• Experience in FSP or similar client-embedded roles (preferred)

Qualifications:

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

• Minimum of 3+ years in regulatory affairs for a Regulatory Project Manager role with a focus on strategic planning and project management; minimum of 5+ years of relevant experience for a Senior Regulatory Project Manager role; and a minimum of 7+ years of experience in regulatory affairs project management, with at least 3-5 years in a senior leadership role for a Senior Regulatory Project Management Consultant.

• 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 the US or Canada in other regions who have the ability to work EST hours.

These roles offer the opportunity to work with a dedicated client, providing consistent, high-quality regulatory support while developing deep expertise in their product portfolio and processes. You'll be part of a growing team, with potential for career advancement as our partnership expands.

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.

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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.