Regulatory Project Manager

Parexel

. Oversee operational execution of diverse regulatory projects .

Posted 10/5/2026full-timeRemote • United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory project management, ensuring compliance and timely delivery of submissions while effectively collaborating with clients and stakeholders. Possesses strong leadership and communication skills, with a proven ability to manage complex projects and drive strategic regulatory initiatives.

Highest-signal resume keywords

Regulatory AffairsProject ManagementRegulatory SubmissionsStakeholder ManagementGlobal Regulatory Requirements

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Project ManagementRegulatory SubmissionsProject TimelinesRisk MitigationStrategic PlanningGlobal Regulatory ProcessesTherapeutic Areas KnowledgeProblem-SolvingClient Relationship ManagementLeadership Experience

Soft Skills

Organizational SkillsCommunication SkillsCustomer Service SkillsAdaptabilityCollaboration

Certifications & Qualifications

Bachelor's Degree in Relevant Scientific FieldAdvanced Degree (PharmD, PhD, or Equivalent) Preferred

Industry Keywords

Regulatory ComplianceFDA LiaisonInterdisciplinary MeetingsClient-Specific ProcessesForeign Language Skills

About the role

Key responsibilities & impact

Oversee operational execution of diverse regulatory projects
Ensure timely delivery of high-quality regulatory submissions
Contribute to long-term strategic planning for clients’ regulatory initiatives
Manage project scope and budget
Identify and mitigate potential risks while maintaining strict regulatory compliance
Collaborate with client teams and internal stakeholders
Drive continuous improvement in regulatory processes and methodologies
Facilitate interdisciplinary meetings as the main client and internal contact and FDA liaison, representing sponsors as US Agent when requested
Build client relationships and gain new and repeat business
Partner with multiple clients and contribute to their regulatory programs

Requirements

What you’ll need

US-based Regulatory Project Manager
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, stakeholder management, and customer service skills
Ability to adapt to client-specific processes and culture
Prompt communication and strong understanding of work prioritization and urgencies
Proactive problem-solving and risk mitigation
Fluency in Japanese, Chinese, or Korean highly preferred; foreign language skills are a plus
Bachelor's degree in a relevant scientific field required; advanced degree (PharmD, PhD, or equivalent) preferred
Minimum of 3+ years in a regulatory affairs-related project management role
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
Strategic thinking and ability to translate regulatory insights into business opportunities
Ability to manage multiple complex projects simultaneously
Ability to influence and collaborate effectively across all organizational levels
Leadership experience, including mentoring and developing team members
Adaptability and resilience in changing regulatory environments and organizational priorities
Ability to work EST hours; candidates in other US time zones may be considered

Benefits

Comp & perks

Home-based/remote work
Potential for career advancement