Strategic Regulatory Project Manager

Parexel; Atlanta (GA); Remote; USD 120,000 - 150,000; Full time

Job summary

Parexel is seeking experienced, proactive US-based Regulatory Project Managers for home-based roles. You will oversee regulatory projects, ensure timely submissions, and contribute to strategic client initiatives.

Ideal candidates have strong regulatory affairs background, excellent organization, and leadership skills, with a track record in global submissions and stakeholder management. EST hours preferred; growth opportunities across healthcare clients.

Qualifications

• Bachelor's degree in a relevant scientific field; advanced degree preferred.
• Minimum of 3+ years in a regulatory affairs related project management role.
• Proven track record leading global regulatory projects and milestones.
• In-depth knowledge of global regulatory requirements across therapies.
• Strong strategic thinking and translating regulatory insights into opportunities.
• Excellent project management across multiple complex projects.

Responsibilities

• 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 risks while maintaining regulatory compliance.
• Collaborate with clients’ teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies.
• Serve as US Agent liaison and FDA contact as requested.
• Build client relationships and secure repeat business.

Skills

Regulatory affairs

Project management

Organizational skills

Regulatory submissions

Timeline management

Leadership

Stakeholder management

Communication

Risk mitigation

Foreign language skills (Japanese/Chn/

Education

Bachelor's in a relevant scientific field

Advanced degree ( PharmD/PhD or equivalent ) preferred

Job description

Parexel is seeking experienced, proactive US-based Regulatory Project Managers for home-based roles. You will oversee regulatory projects, ensure timely submissions, and contribute to strategic client initiatives.

Ideal candidates have strong regulatory affairs background, excellent organization, and leadership skills, with a track record in global submissions and stakeholder management. EST hours preferred; growth opportunities across healthcare clients.