When our values align, there's no limit to what we can achieve.
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.
The Regulatory Affairs Senior Specialist or 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
Skills Required
- Minimum 3-5 years of regulatory affairs experience
- Experience preparing INDs and NDA/BLAs
- Working knowledge of GMP, GLP, and GCP regulations
- Understanding of the pharmaceutical product life cycle
- Written and oral fluency in English, Cantonese, and Mandarin
- Bachelor's degree in a relevant field
- Advanced degree
Parexel Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Parexel and has not been reviewed or approved by Parexel.
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Healthcare Strength — Health coverage is described as comprehensive, including medical, dental, vision, HSA/FSA options, and company-paid disability insurance. Descriptions often portray the package as strong or “top notch,” adding meaningful value.
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Retirement Support — Retirement offerings include a 401(k) with company matching and, in some regions, generous pension contributions. Core financial protections are emphasized as a solid part of the total rewards.
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Leave & Time Off Breadth — Time-off programs include ample PTO or flexible/unlimited RTO alongside flexible schedules and remote/hybrid options. Work-life balance support from managers is highlighted as a practical advantage.
Parexel Insights
What We Do
Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.
