Remote Regulatory Project Manager – Biotech Submissions

Parexel; Topeka (KS); À distance; USD 100 000 - 140 000; Plein temps

Résumé du poste

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will oversee regulatory projects, ensure timely submissions, and contribute to strategic regulatory initiatives for biotech clients. Excellent leadership, communication, and stakeholder management are essential, with a proactive, problem-solving approach.

EST hours preferred; growth opportunities available. Ideal candidates have a strong regulatory affairs background, proven PM experience, and

Qualifications

• Bachelor's degree in a relevant scientific field; PharmD/PhD or equivalent preferred.
• Minimum 3+ years in regulatory affairs project management.
• Proven track record leading global regulatory projects and milestones.
• Knowledge of global regulatory requirements across multiple therapeutic areas.
• Strong strategic thinking; translate regulatory insights into opportunities.
• Excellent project management across multiple complex projects.
• Outstanding communication and interpersonal skills; influence/in cross-levels.
• Mentoring and developing team members; adapt to client processes and culture.
• EST time-zone preferred; capable of working EST hours for US clients.

Responsabilités

• 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.
• Facilitate meetings as main client contact and FDA liaison; represent sponsors as US Agent as requested.
• Build client relationships and pursue new and repeat business.

Connaissances

Regulatory affairs

Project management

Stakeholder management

Leadership

Communication

Risk mitigation

Timeline management

Client relations

Regulatory submissions

Cross-functional collaboration

Formation

Bachelor's degree in science

Advanced degree (PharmD/PhD) preferred

Description du poste

Parexel is seeking experienced Regulatory Project Managers for US-based, home-based roles. You will oversee regulatory projects, ensure timely submissions, and contribute to strategic regulatory initiatives for biotech clients. Excellent leadership, communication, and stakeholder management are essential, with a proactive, problem-solving approach.

EST hours preferred; growth opportunities available. Ideal candidates have a strong regulatory affairs background, proven PM experience, and