Regulatory Affairs Senior Specialist - Manager

I contribute to clinical research with expertise and empathy. And I do it Search Jobs Search Jobs Keyword Matching job links will appear below as you type. Location: When autocomplete results are available use up and down arrows to review and enter to select. Touch device users, explore by touch or with swipe gestures. Radius: Enter distance 5 15 25 35 50 Unit MILES KM View Remote Jobs View All Jobs View remote jobs View all jobs Regulatory Affairs Senior Specialist - Manager (FSP) Primary Location: Hong Kong, Remote Job ID R0000045813 Category Regulatory / Consulting Date Posted 10/01/2026 Apply Now

• Success profile
• About this role
• Employee insights
• Why Consultants work at Parexel
• Learn about our culture Overview As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there. We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team. Success Profile Do you have these soft skills and interpersonal traits to succeed at Parexel?
• Communicator
• Detail-oriented
• Problem-solver
• Relationship-builder
• Results-driven
• Strategic Back to nav About This Role The Regulatory Affairs Senior Specialist or Consultant (Manager) is responsible for supporting regulatory operations, submission execution, and lifecycle management activities for client's portfolio in Hong Kong and Macau. This role works closely with internal stakeholders, external partners, and Heath Authorities to ensure timely submissions, regulatory compliances, and effective execution of regulatory activities. This FSP role will need to be able to work at client's office (Location: Hong Kong) Key Accountabilities
• Prepare, submit, and track regulatory applications, including clinical trial applications, import permits, marketing applications, variations, and renewals.
• Support product registrations and post-approval lifecycle management activities.
• Coordinate regulatory submission activities with internal teams, external partners, and Health Authorities.
• Maintain regulatory documentation, submission records, and regulatory archives in accordance with company policies and local requirements.
• Support regulatory inspections, audits, and Health Authority requests as needed.
• Develop and maintain local regulatory procedures and working practices.
• Monitor local regulatory requirements and communicate relevant regulatory updates to stakeholders.
• Collaborate cross-functionally to support regulatory and business objectives. Knowledge And Experience
• With a minimum of 3-5-years regulatory affairs experience > Upon experience level, suitable title (Senior Specialist; equivalent to Senior Associate or up to Manager equivalent title) will be offered.
• Experience and knowledge in preparation of INDs and NDA/BLAs
• Working knowledge of GMP, GLP, and GCP regulations as well an understanding of the pharmaceutical product life cycle
• Command of written and oral English, Cantonese, and Mandarin
• Travel: As required by the company. Education
• Minimum of a Bachelor's Degree in a relevant study field
• Advanced Degree Preferred Back to nav Share this job
• LinkedIn
• Facebook
• X
• Email Employee Insights How to describe Parexel culture in one word Insights from Parexel employees Watch Video Jo on diverse project work and team culture Jo Wang | Vice President, Technical Watch Video Kurt on colleagues and growth opportunities Kurt Brorson | Vice President, Technical Watch Video Back to nav Why Consultants work at Parexel Patient-led in everything we do We are inspired by the patients behind the data and therefore deliver first-time quality and on-time projects. Supportive and inclusive environment We thrive on collaboration, caring, and inclusivity - enabling our people to work together to solve complex problems and share knowledge. Opportunities for career growth We provide a wide range of challenging assignments, product types, geographic regions, and therapeutic areas, providing ample opportunities for learning and growth. Flexible work arrangements We offer the flexibility of remote work, allowing you to balance your personal and professional responsibilities while still contributing to our “We Care” team environment. Diverse and global client exposure We continuously learn by working with a global network of colleagues and clients to develop regulatory strategies to support their product development and approval. Learn from experts You will work with a team of highly experienced regulatory professionals who can serve as mentors, providing guidance and support as you develop your skills and advance in your career. Back to nav Learn About Our Culture Back to nav Back to nav
• Benefits & Support At Parexel, we prioritize putting people first, allowing you to achieve your best work. Explore the Flexible Work Program, our "Bravo" Recognition Program, and how we build our well-being in our supportive culture. Learn More
• Inclusion at Parexel Learn how Parexel celebrates the differences our workforce and patients bring and ensures an inclusive environment. Learn More
• Emerging Talent Opportunities Begin your career journey at Parexel with our emerging talent programs or our internships, placements and entry-level clinical roles. Advance science by keeping the patients in mind. Learn More