Regulatory Project Manager

Parexel•Southport, NC

4d•Remote

About The Position

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. 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.

Requirements

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
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.
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.

Nice To Haves

Advanced degree (PharmD, PhD, or equivalent) preferred.
Foreign language skills are a plus with fluency in Japanese, Chinese, or Korean highly preferred.

Responsibilities

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