Jobs at Parexel
Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.
Regulatory Project Manager
Job ID R0000046571We 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.
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