Remote Regulatory PM — Global Submissions & Growth

Parexel; Salem (OR); Remote; USD 110,000 - 160,000; Full time

Job summary

Parexel is expanding its Regulatory Project Management team with US-based, home-based roles. You will oversee the operational execution of diverse regulatory projects, ensuring timely submissions and contributing to strategic planning for biotech clients.

You will manage scope, budget, and risks while collaborating with client teams, internal stakeholders, and regulatory authorities. The role emphasizes strong leadership, communication, and stakeholder management, with a flexible EST-hour

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.

Responsibilities

• Oversee the operational execution of diverse regulatory projects and ensure timely delivery of high-quality regulatory submissions.
• Contribute to long-term strategic planning for the clients’ regulatory initiatives and manage project scope and budget.
• Identify and mitigate risks while maintaining strict regulatory compliance and collaborating with client teams and internal stakeholders.
• Drive continuous improvement in regulatory processes and methodologies and facilitate interdisciplinary meetings as primary client and internal contact.
• Represent Parexel as US Agent when requested and build strong client relationships to win new and repeat business.

Skills

Regulatory affairs

Project management

Organizational skills

Leadership

Stakeholder management

Communication

Risk mitigation

Client relationships

Prioritization

Customer service

Problem solving

Japanese

Chinese

Korean

Foreign language skills

Education

Bachelor's degree in a relevant scientific field

Advanced degree (PharmD, PhD, or equivalent)

Job description

Parexel is expanding its Regulatory Project Management team with US-based, home-based roles. You will oversee the operational execution of diverse regulatory projects, ensuring timely submissions and contributing to strategic planning for biotech clients.

You will manage scope, budget, and risks while collaborating with client teams, internal stakeholders, and regulatory authorities. The role emphasizes strong leadership, communication, and stakeholder management, with a flexible EST-hour