Regulatory Project Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Supervise the operational implementation of a variety of regulatory projects.

• Guarantee the timely submission of high-quality regulatory documents.

• Participate in long-term strategic planning for clients' regulatory efforts.

• Oversee project scope and financial aspects.

• Recognize and alleviate potential risks while ensuring strict adherence to regulatory standards.

• Collaborate with client teams and internal partners.

• Promote ongoing improvements in regulatory processes and methodologies.

• Lead interdisciplinary meetings as the primary contact for clients and internal teams, acting as the FDA liaison and representing sponsors as US Agent when required.

• Cultivate client relationships to secure new and repeat business.

• Work in partnership with multiple clients and enhance their regulatory programs.

⛳️ Requirements

• Regulatory Project Manager based in the US.

• Strong expertise in regulatory affairs and project management.

• Exceptional organizational capabilities.

• Documented history of successful regulatory submissions.

• Previous experience in developing and revising project timelines.

• Excellent leadership, communication, stakeholder management, and customer service abilities.

• Capacity to adapt to client-specific processes and cultural nuances.

• Timely communication and a solid comprehension of work prioritization and urgency.

• Proactive in problem-solving and risk management.

• Proficiency in Japanese, Chinese, or Korean is highly preferred; additional foreign language skills are advantageous.

• A bachelor's degree in a relevant scientific discipline is required; an advanced degree (PharmD, PhD, or equivalent) is preferred.

• A minimum of 3+ years of experience in a regulatory affairs-focused project management position.

• Proven success in leading global regulatory projects and meeting crucial milestones.

• Comprehensive knowledge of global regulatory requirements and processes across various therapeutic fields.

• Strategic mindset with the ability to convert regulatory insights into business opportunities.

• Capability to manage multiple intricate projects concurrently.

• Proficiency in influencing and collaborating effectively across all organizational tiers.

• Leadership experience that includes mentoring and developing team members.

• Flexibility and resilience in adapting to changing regulatory landscapes and organizational priorities.

• Availability to work during EST hours; candidates from other US time zones may also be considered.

🏝️ Benefits

• Remote/home-based work.

• Opportunities for career advancement.